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Re-engineering the clinical approach to suspected cardiac chest pain assessment in the emergency department by expediting research evidence to practice using artificial intelligence. (RAPIDx AI)—a cluster randomized study design
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-22 DOI: 10.1016/j.ahj.2025.02.016
Ehsan Khan MBBS, MMed (Clin Epi) , Kristina Lambrakis BSc , Tom Briffa PhD , Louise A Cullen MBBS, PhD , Jonathon Karnon , Cynthia Papendick MBBS , Stephen Quinn PhD , Phil Tideman , Anton Van Den Hengel , Johan Verjans , Derek P Chew MBBS, MPH, PhD
{"title":"Re-engineering the clinical approach to suspected cardiac chest pain assessment in the emergency department by expediting research evidence to practice using artificial intelligence. (RAPIDx AI)—a cluster randomized study design","authors":"Ehsan Khan MBBS, MMed (Clin Epi) ,&nbsp;Kristina Lambrakis BSc ,&nbsp;Tom Briffa PhD ,&nbsp;Louise A Cullen MBBS, PhD ,&nbsp;Jonathon Karnon ,&nbsp;Cynthia Papendick MBBS ,&nbsp;Stephen Quinn PhD ,&nbsp;Phil Tideman ,&nbsp;Anton Van Den Hengel ,&nbsp;Johan Verjans ,&nbsp;Derek P Chew MBBS, MPH, PhD","doi":"10.1016/j.ahj.2025.02.016","DOIUrl":"10.1016/j.ahj.2025.02.016","url":null,"abstract":"<div><h3>Background</h3><div>Clinical work-up for suspected cardiac chest pain is resource intensive. Despite expectations, high-sensitivity cardiac troponin assays have not made decision making easier. The impact of recently validated rapid triage protocols including the 0-hour/1-hour hs-cTn protocols on care and outcomes may be limited by the heterogeneity in interpretation of troponin profiles by clinicians. We have developed machine learning (ML) models which digitally phenotype myocardial injury and infarction with a high predictive performance and provide accurate risk assessment among patients presenting to EDs with suspected cardiac symptoms. The use of these models may support clinical decision-making and allow the synthesis of an evidence base particularly in non-T1MI patients however prospective validation is required.</div></div><div><h3>Objective</h3><div>We propose that integrating validated real-time artificial intelligence (AI) methods into clinical care may better support clinical decision-making and establish the foundation for a self-learning health system.</div></div><div><h3>Design</h3><div>This prospective, multicenter, open-label, cluster-randomized clinical trial within blinded endpoint adjudication across 12 hospitals (n = 20,000) will randomize sites to the clinical decision-support tool or continue current standard of care. The clinical decision support tool will utilize ML models to provide objective patient-specific diagnostic probabilities (ie, likelihood for Type 1 myocardial infarction [MI] versus Type 2 MI/Acute Myocardial Injury versus Chronic Myocardial Injury etc.) and prognostic assessments. The primary outcome is the composite of cardiovascular mortality, new or recurrent MI and unplanned hospital re-admission at 12 months post index presentation.</div></div><div><h3>Summary</h3><div>Supporting clinicians with a decision support tool that utilizes AI has the potential to provide better diagnostic and prognostic assessment thereby improving clinical efficiency and establish a self-learning health system continually improving risk assessment, quality and safety.</div></div><div><h3>Trial registration</h3><div>ANZCTR, Registration Number: ACTRN12620001319965, <span><span>https://www.anzctr.org.au/</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 106-118"},"PeriodicalIF":3.7,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143490509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effects of carvedilol on the prevention of cardiotoxicity induced by anthracyclines: Design and rationale of the CARDIOTOX trial
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-22 DOI: 10.1016/j.ahj.2025.02.014
Isabela Bispo Santos da Silva Costa MD, PhD , Remo H.M. Furtado MD, PhD , Luciano F. Drager MD, PhD , Pedro Gabriel Melo de Barros e Silva MD, PhD , Marcelo Dantas Tavares de Melo MD, PHD , Paula Araruna MD , Bruno C. Bacchiega MD , Sanderson Cauduro MD , Edilson Walter MD , Guilherme Loureiro Fialho MD, PhD , Odilson Silvestre MD, PhD, MPH , Lucas P. Damiani PhD , Lilian M. Barbosa MSc, MBA , Mariane Nascimento Luz Bsc , Ana Cecilia Alcantara Silva Bsc , Renata Rodrigues de Mattos MBA , Roberta Saretta MD , Marilia Harumi H.S. Rehder MD, PhD , Ludhmila Abrahao Hajjar MD, PhD , Teresa Lopes-Fernandez MD , Roberto Kalil Filho MD, PhD
{"title":"Effects of carvedilol on the prevention of cardiotoxicity induced by anthracyclines: Design and rationale of the CARDIOTOX trial","authors":"Isabela Bispo Santos da Silva Costa MD, PhD ,&nbsp;Remo H.M. Furtado MD, PhD ,&nbsp;Luciano F. Drager MD, PhD ,&nbsp;Pedro Gabriel Melo de Barros e Silva MD, PhD ,&nbsp;Marcelo Dantas Tavares de Melo MD, PHD ,&nbsp;Paula Araruna MD ,&nbsp;Bruno C. Bacchiega MD ,&nbsp;Sanderson Cauduro MD ,&nbsp;Edilson Walter MD ,&nbsp;Guilherme Loureiro Fialho MD, PhD ,&nbsp;Odilson Silvestre MD, PhD, MPH ,&nbsp;Lucas P. Damiani PhD ,&nbsp;Lilian M. Barbosa MSc, MBA ,&nbsp;Mariane Nascimento Luz Bsc ,&nbsp;Ana Cecilia Alcantara Silva Bsc ,&nbsp;Renata Rodrigues de Mattos MBA ,&nbsp;Roberta Saretta MD ,&nbsp;Marilia Harumi H.S. Rehder MD, PhD ,&nbsp;Ludhmila Abrahao Hajjar MD, PhD ,&nbsp;Teresa Lopes-Fernandez MD ,&nbsp;Roberto Kalil Filho MD, PhD","doi":"10.1016/j.ahj.2025.02.014","DOIUrl":"10.1016/j.ahj.2025.02.014","url":null,"abstract":"<div><h3>Background</h3><div>Patients with cancer undergoing chemotherapy with an anthracycline-based regimen are at increased risk of cardiotoxicity, predisposing to heart failure, arrhythmias and death. Whether carvedilol may confer benefit to prevent anthracycline-induced cardiotoxicity remains to be determined.</div></div><div><h3>Design</h3><div>CARDIOTOX is a double-blind, placebo controlled randomized clinical trial that plan to enroll 1,018 patients across 25 study sites in Brazil. Patients with active cancer scheduled to undergo an anthracycline-based chemotherapy regimen are eligible. Patients with prior HF or cardiomyopathy are excluded. Patients are randomized in 1:1 ratio to carvedilol (starting dose 6.25mg BID up titrated to 25mg BID or maximum tolerated dose) or placebo, stratified by site and use of renin-angiotensin blockers at baseline. Study drug is administered through the duration of chemotherapy and up to 30 days after the last dose of anthracycline. Patients are scheduled to undergo echocardiographic evaluations at baseline and at 3, 6, and 12 months. The study primary endpoint is the composite of new left ventricle ejection fraction (LVEF) reduction by at least 10% leading to an LVEF &lt;50%, cardiovascular death, myocardial infarction, urgent care visit or hospitalization for heart failure, or clinically significant arrhythmias at 12 months. Echocardiographic images will be analyzed by a central core lab, clinical outcomes will be adjudicated, and safety endpoints include serious adverse events and adverse events of special interest (symptomatic bradycardia, hypotension, syncope and bronchospasm).</div></div><div><h3>Summary</h3><div>The CARDIOTOX trial is the largest trial to date analyzing the potential role of beta-blockers as prophylactic therapy to prevent cardiotoxicity induced by anthracyclines.</div></div><div><h3>Trial Registration</h3><div>Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy (CardioTox). ClinicalTrials.gov ID NCT04939883. <span><span>https://clinicaltrials.gov/study/NCT04939883</span><svg><path></path></svg></span></div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 1-11"},"PeriodicalIF":3.7,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482114","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Reminders embedded in PCI reports to optimize discharge diabetes mellitus care (REMIND-DM): Rationale, design, and baseline characteristics
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-21 DOI: 10.1016/j.ahj.2025.01.020
Safia Chatur MD , Milan Seth MS , Mary Casey MPA , Michael P Thompson PhD, MPH , M. Imran Qureshi MD , Vishal Gupta MD , Mansoor Qureshi MD , Bashar Samman MD , Annemarie Forest MS, MPH , Hitinder S Gurm MD , Devraj Sukul MD, MSc , Muthiah Vaduganathan MD MPH
{"title":"Reminders embedded in PCI reports to optimize discharge diabetes mellitus care (REMIND-DM): Rationale, design, and baseline characteristics","authors":"Safia Chatur MD ,&nbsp;Milan Seth MS ,&nbsp;Mary Casey MPA ,&nbsp;Michael P Thompson PhD, MPH ,&nbsp;M. Imran Qureshi MD ,&nbsp;Vishal Gupta MD ,&nbsp;Mansoor Qureshi MD ,&nbsp;Bashar Samman MD ,&nbsp;Annemarie Forest MS, MPH ,&nbsp;Hitinder S Gurm MD ,&nbsp;Devraj Sukul MD, MSc ,&nbsp;Muthiah Vaduganathan MD MPH","doi":"10.1016/j.ahj.2025.01.020","DOIUrl":"10.1016/j.ahj.2025.01.020","url":null,"abstract":"<div><h3>Background</h3><div>Despite the robust clinical evidence base supporting their role for high-risk patients with type 2 diabetes (T2DM) and concomitant cardiovascular disease, prescription of sodium-glucose co-transporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RA) remains suboptimal. Clinical encounters occurring in the period post angiography may present a key opportunity to improve implementation in high-risk patients with T2DM.</div></div><div><h3>Methods</h3><div><em>R</em>eminders <em>EM</em>bedded <em>IN</em> PCI Reports to Optimize Discharge <em>D</em>iabetes <em>M</em>ellitus Care (REMIND-DM) is a pragmatic, prospective, cluster randomized quality improvement study in patients with type 2 diabetes undergoing angiography and was run as a quality improvement initiative. Following a 6 month “baseline period”, REMIND-DM randomized 23 participating percutaneous coronary intervention (PCI) sites (caring for 7,045 patients over the study period) within the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) quality improvement collaborative to either usual care or a quality improvement intervention consisting of a templated PCI report “reminder” of medication eligibility linked to a decision support tool. Sites were followed for a 6 month “evaluation period.” The primary outcome is the new prescription of SGLT2 inhibitor or GLP-1RA among eligible patients at discharge after PCI. To examine the effectiveness of the intervention, primary analyses will be conducted using a difference-in-difference design examining changes in new cardioprotective therapy prescription from baseline to the evaluation periods in both arms.</div></div><div><h3>Conclusions</h3><div>The REMIND-DM implementation trial has enrolled a large, high-risk population of patients with T2DM and will determine the effectiveness of a low touch QI intervention within BMC2 implemented in the post-PCI period to improve timely prescription of risk lowering therapies in high-risk patients with T2DM.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 12-20"},"PeriodicalIF":3.7,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482116","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Information for Readers
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-21 DOI: 10.1016/S0002-8703(25)00051-1
{"title":"Information for Readers","authors":"","doi":"10.1016/S0002-8703(25)00051-1","DOIUrl":"10.1016/S0002-8703(25)00051-1","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"282 ","pages":"Page iv"},"PeriodicalIF":3.7,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143453686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Oral factor xia inhibitor milvexian after a recent acute coronary syndrome: Rationale and design of the phase 3 (Librexia ACS)
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-20 DOI: 10.1016/j.ahj.2025.02.011
C. Michael Gibson MD, MS , M. Cecilia Bahit MD , Roxana Mehran MD , Shamir R. Mehta MD , Rasha Al Lamee MD , Shinya Goto MDPhD , Jeffrey I. Weitz MD , Jay Horrow MDMS , Elliot S. Barnathan MD , Robert A. Harrington MD , Kenneth W. Mahaffey MD , Carolyn S.P. Lam MBBS, PhD , Karen S. Pieper MS , S. Claiborne Johnston MD, PhD , Graeme J. Hankey MBBS, MD , Alexei N. Plotnikov MD , Danshi Li MD, PhD , Hsiaowei Deng PhD , Philippe Gabriel Steg MD , Librexia ACS Committees and Investigators.
{"title":"Oral factor xia inhibitor milvexian after a recent acute coronary syndrome: Rationale and design of the phase 3 (Librexia ACS)","authors":"C. Michael Gibson MD, MS ,&nbsp;M. Cecilia Bahit MD ,&nbsp;Roxana Mehran MD ,&nbsp;Shamir R. Mehta MD ,&nbsp;Rasha Al Lamee MD ,&nbsp;Shinya Goto MDPhD ,&nbsp;Jeffrey I. Weitz MD ,&nbsp;Jay Horrow MDMS ,&nbsp;Elliot S. Barnathan MD ,&nbsp;Robert A. Harrington MD ,&nbsp;Kenneth W. Mahaffey MD ,&nbsp;Carolyn S.P. Lam MBBS, PhD ,&nbsp;Karen S. Pieper MS ,&nbsp;S. Claiborne Johnston MD, PhD ,&nbsp;Graeme J. Hankey MBBS, MD ,&nbsp;Alexei N. Plotnikov MD ,&nbsp;Danshi Li MD, PhD ,&nbsp;Hsiaowei Deng PhD ,&nbsp;Philippe Gabriel Steg MD ,&nbsp;Librexia ACS Committees and Investigators.","doi":"10.1016/j.ahj.2025.02.011","DOIUrl":"10.1016/j.ahj.2025.02.011","url":null,"abstract":"<div><h3>Background</h3><div>Despite current antiplatelet therapy, patients remain at risk of recurrent ischemic events after acute coronary syndromes (ACS), which may reflect persistently elevated thrombin generation. Factor XIa inhibition reduces thrombin generation and may improve clinical outcomes with minimal bleeding risk.</div></div><div><h3>Design</h3><div>Librexia ACS (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> NCT05754957) is a Phase 3, randomized, double-blind, placebo-controlled, event-driven trial to test the efficacy and safety of milvexian, an oral, selective factor XIa inhibitor, in addition to conventional antiplatelet therapy after a recent ACS. Eligibility criteria include symptoms of spontaneous ischemia, a diagnosis of ACS and cardiac biomarker elevation indicative of myonecrosis within 7 days before randomization, along with at least 2 risk-enhancing factors. Participants are randomly assigned to oral milvexian (25 mg twice daily) or a matched placebo. Randomization is stratified according to the planned duration and type of antiplatelet therapy. The primary efficacy endpoint is the time to first occurrence of the composite of cardiovascular death, myocardial infarction (MI), or ischemic stroke that will enroll approximately 16,000 patients with follow-up until 875 events are accrued. The first major secondary endpoint is time to the first occurrence of cardiovascular death, MI, ischemic stroke, major adverse limb events, and symptomatic venous thromboembolism. The principal safety endpoint is Bleeding Academic Research Consortium 3c or 5 bleeding.</div></div><div><h3>Summary</h3><div>The Librexia-ACS trial will determine the efficacy and safety of milvexian after ACS and will be the first trial to test whether factor XIa inhibition in addition to standard-of-care antiplatelet therapy reduces major adverse cardiovascular events without an increased risk of significant bleeding.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 21-28"},"PeriodicalIF":3.7,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476208","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: Rationale and design of a randomized controlled trial
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-20 DOI: 10.1016/j.ahj.2025.02.007
Nancy Haff MD, MPH , Daniel M Horn MD , Gauri Bhatkhande MPH , Meekang Sung PharmD, MS , Caitlin Colling MD , Wendy Wood PhD , Ted Robertson MPA , Daniel Gaposchkin MD, PhD , Leigh Simmons MD , Judy Yang MD , James Yeh MD, MPH , Katherine L. Crum BA , Kaitlin E. Hanken MPH , Julie C. Lauffenburger PharmD, PhD , Niteesh K. Choudhry MD, PhD
{"title":"Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: Rationale and design of a randomized controlled trial","authors":"Nancy Haff MD, MPH ,&nbsp;Daniel M Horn MD ,&nbsp;Gauri Bhatkhande MPH ,&nbsp;Meekang Sung PharmD, MS ,&nbsp;Caitlin Colling MD ,&nbsp;Wendy Wood PhD ,&nbsp;Ted Robertson MPA ,&nbsp;Daniel Gaposchkin MD, PhD ,&nbsp;Leigh Simmons MD ,&nbsp;Judy Yang MD ,&nbsp;James Yeh MD, MPH ,&nbsp;Katherine L. Crum BA ,&nbsp;Kaitlin E. Hanken MPH ,&nbsp;Julie C. Lauffenburger PharmD, PhD ,&nbsp;Niteesh K. Choudhry MD, PhD","doi":"10.1016/j.ahj.2025.02.007","DOIUrl":"10.1016/j.ahj.2025.02.007","url":null,"abstract":"<div><h3>Background</h3><div>Sodium-glucose cotransporter-2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1RA) medications reduce the risk of cardiovascular and renal complications among patients with type 2 diabetes but are underutilized. There are numerous barriers to prescribing including insurance coverage, medication availability, comfort with prescribing, and diffusion of responsibility of prescribing across specialists. Methods are needed to support prescribing in primary care.</div></div><div><h3>Methods</h3><div>This was a pragmatic, randomized controlled trial testing interventions to increase appropriate SGLT2i and GLP-1RA prescribing. Primary care providers (PCPs) were randomized to 1 of 3 arms: (1) peer champion support (2) peer champion support and information on insurance coverage, or (3) usual care (no intervention). PCPs in both intervention arms received a welcome email and electronic health record (EHR) messages before visits with patients who had sub-optimally controlled diabetes and an indication for 1 of these medications. In the peer champion support only arm the EHR messages included prescribing tips. In the arm that provided peer champion support and information on insurance coverage, EHR messages contained information on medications in each class that would be most affordable for the patient based on their insurance coverage and offered support for prior authorizations if needed. The primary outcome was prescriptions for an SGLT2i or GLP-1RA medication, beginning 3 days before the targeted visit and continuing through 28 days, in each intervention arm compared to control.</div></div><div><h3>Results</h3><div>191 primary care providers were included in the study. 1,389 patients had at least 1 visit scheduled with their PCP during the 6-month intervention period; of these 1,079 patients attended at least 1 of these visits and will be included in the primary outcome analysis. 66 providers (484 patients) received the peer champion intervention alone, 63 providers (446 patients) received the peer champion intervention and information on insurance coverage, and 62 providers (459 patients) received usual care. On average, patients were 66 years old, 46% were female, 61% were white, and 16% were Hispanic. There were small differences between groups with regards to patient sex, race, ethnicity, partner status, and percent with Medicare insurance.</div></div><div><h3>Conclusions</h3><div>These medication classes have the potential to reduce cardiovascular and kidney disease among patients with type 2 diabetes. This study tests interventions to support prescribing of these medications in primary care.</div></div><div><h3>Clinical Trial</h3><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span>. Unique identifier: (NCT, Registered: NCT05463705).</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 39-51"},"PeriodicalIF":3.7,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Functional coronary angiography to indicate and guide revascularization in STEMI patients with multivessel disease: Rationale and design of the AIR-STEMI trial
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-19 DOI: 10.1016/j.ahj.2025.02.012
Andrea Erriquez MD , Iginio Colaiori MD , Abdul Hakeem MD , Vincenzo Guiducci MD , Mila Menozzi MD , Marco Barbierato MD , Manfredi Arioti MD , Domenico D'Amario MD , Gianni Casella MD , Roberto Scarsini MD , Alberto Polimeni MD , Luca Donazzan MD , Giorgio Benatti MD , Gabriele Venturi MD , Marco Ruozzi MD , Massimo Giordan MD , Alberto Monello MD , Francesco Moretti MD , Francesco Versaci MD , Jehangir Ali Shah MD , Simone Biscaglia MD
{"title":"Functional coronary angiography to indicate and guide revascularization in STEMI patients with multivessel disease: Rationale and design of the AIR-STEMI trial","authors":"Andrea Erriquez MD ,&nbsp;Iginio Colaiori MD ,&nbsp;Abdul Hakeem MD ,&nbsp;Vincenzo Guiducci MD ,&nbsp;Mila Menozzi MD ,&nbsp;Marco Barbierato MD ,&nbsp;Manfredi Arioti MD ,&nbsp;Domenico D'Amario MD ,&nbsp;Gianni Casella MD ,&nbsp;Roberto Scarsini MD ,&nbsp;Alberto Polimeni MD ,&nbsp;Luca Donazzan MD ,&nbsp;Giorgio Benatti MD ,&nbsp;Gabriele Venturi MD ,&nbsp;Marco Ruozzi MD ,&nbsp;Massimo Giordan MD ,&nbsp;Alberto Monello MD ,&nbsp;Francesco Moretti MD ,&nbsp;Francesco Versaci MD ,&nbsp;Jehangir Ali Shah MD ,&nbsp;Simone Biscaglia MD","doi":"10.1016/j.ahj.2025.02.012","DOIUrl":"10.1016/j.ahj.2025.02.012","url":null,"abstract":"<div><h3>Background</h3><div>Complete revascularization has been shown to be superior to culprit-only treatment in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. However, it remains unclear whether complete revascularization should be guided by coronary physiology or conventional angiography. Angiography-derived physiology may allow functional assessment and procedural guidance using angiograms from primary percutaneous coronary intervention (PCI), potentially maximizing the benefits of a physiology-guided approach. We present the design of a dedicated study that will address this research gap.</div></div><div><h3>Methods and Design</h3><div>The Functional Coronary Angiography to Indicate and Guide Revascularization in STEMI Patients with Multivessel Disease (AIR-STEMI) trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. After successful treatment of the culprit lesion, patients will be randomized to receive PCI of the nonculprit lesions guided by conventional angiography or by angiography-derived fractional flow reserve (FFR). The primary endpoint is the composite endpoint of all-cause death, any myocardial infarction (MI), any cerebrovascular accident, or any revascularization. It will be censored once the last enrolled patient reaches 1-year follow-up. The secondary endpoint will be the composite of cardiovascular death or MI and each single component of the primary endpoint. All endpoints will be tested also at 3 and 5 years. The sample size for the study is a minimum of 1,800 patients.</div></div><div><h3>Implications</h3><div>The AIR-STEMI trial will provide novel evidence on whether a specific complete revascularization strategy should be applied to patients with STEMI and multivessel disease to improve their clinical outcomes.</div></div><div><h3>Trial Registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> NCT05818475.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 71-80"},"PeriodicalIF":3.7,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ventricular-arterial coupling is associated with clinical outcomes in patients with systemic right ventricle
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-19 DOI: 10.1016/j.ahj.2025.02.013
Giulia Pasqualin MD , Amrit Misra MD , Kimberlee Gauvreau ScD , Stephen P. Sanders MD , Akshay S. Desai MD , Alex Alexander PA-C , Ashwin Prakash MD , Michael M. Givertz MD , Anne Marie Valente MD
{"title":"Ventricular-arterial coupling is associated with clinical outcomes in patients with systemic right ventricle","authors":"Giulia Pasqualin MD ,&nbsp;Amrit Misra MD ,&nbsp;Kimberlee Gauvreau ScD ,&nbsp;Stephen P. Sanders MD ,&nbsp;Akshay S. Desai MD ,&nbsp;Alex Alexander PA-C ,&nbsp;Ashwin Prakash MD ,&nbsp;Michael M. Givertz MD ,&nbsp;Anne Marie Valente MD","doi":"10.1016/j.ahj.2025.02.013","DOIUrl":"10.1016/j.ahj.2025.02.013","url":null,"abstract":"<div><h3>Background</h3><div>Adults with transposition of the great arteries (TGA) and systemic right ventricle (SRV) are at risk for heart failure (HF) and decreased survival. Ventricular-arterial coupling (VAC) quantifies the interaction between myocardial contractile function and the load imposed by the arterial circulation and may be valuable in identifying subclinical SRV dysfunction. The purpose of our study is to determine the association of VAC with adverse clinical outcomes in adults with TGA and SRV.</div></div><div><h3>Methods</h3><div>A single center, retrospective cohort study of subjects ≥16 years of age with TGA and SRV who underwent a cardiac magnetic resonance (CMR) examination. VAC was calculated as the ratio between CMR-derived SRV end-systolic volume and stroke volume. Cox proportional hazards regression analysis was performed to assess the association of VAC with clinical outcomes.</div></div><div><h3>Results</h3><div>One hundred sixty-seven subjects (mean age 32 ± 10 years, 59% males) were evaluated. VAC predicted the composite outcome of death, cardiac arrest and HF hospitalizations (hazard ratio (HR) 2.09; 95% CI, 1.12-3.92, <em>P</em> = .02), as well as other cardiovascular hospitalizations including device implantation and percutaneous or surgical structural intervention (HR 1.65, 95% CI, 1.09-2.49, <em>P</em> = .02) after adjustment for age, sex, and the presence of significant tricuspid regurgitation.</div></div><div><h3>Conclusions</h3><div>VAC is associated with major clinical adverse outcomes in patients with TGA and SRV, and may improve risk stratification of this complex population.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 29-38"},"PeriodicalIF":3.7,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implementing depression treatment for cardiac populations in rapidly changing contexts: Design of the hybrid effectiveness-implementation IHEART DEPCARE trial
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-18 DOI: 10.1016/j.ahj.2025.02.009
Andrea T. Duran PhD , Jennifer Mizhquiri Barbecho MPH , Kaitlin Shaw MPH , Siqin Ye MD, MS , Nohora Ospina BA , Samantha Simantiris BA , Joseph E. Schwartz PhD , Nathalie Moise MD, MS
{"title":"Implementing depression treatment for cardiac populations in rapidly changing contexts: Design of the hybrid effectiveness-implementation IHEART DEPCARE trial","authors":"Andrea T. Duran PhD ,&nbsp;Jennifer Mizhquiri Barbecho MPH ,&nbsp;Kaitlin Shaw MPH ,&nbsp;Siqin Ye MD, MS ,&nbsp;Nohora Ospina BA ,&nbsp;Samantha Simantiris BA ,&nbsp;Joseph E. Schwartz PhD ,&nbsp;Nathalie Moise MD, MS","doi":"10.1016/j.ahj.2025.02.009","DOIUrl":"10.1016/j.ahj.2025.02.009","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Rationale&lt;/h3&gt;&lt;div&gt;Few coronary heart disease (CHD) patients engage in &lt;em&gt;evidence-based depression treatments&lt;/em&gt; (ie, antidepressants, therapy, exercise). We present the protocol and analysis plan for a hybrid type II effectiveness-implementation trial evaluating the impact of a theory-informed, multilevel &lt;em&gt;implementation strategy&lt;/em&gt; centered around an electronic shared decision making (eSDM)/patient activation tool.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Design&lt;/h3&gt;&lt;div&gt;The IHEART DEPCARE Trial uses a pre-post single group, open label design with 4 sites (each with a cluster of cardiology clinics and a cluster of primary care clinics, 8 clusters in total) introduced to the multilevel strategy (ie, single arm) in random order with patients (a pre-implementation cohort and nonoverlapping post-implementation cohort) nested within clinicians, nested within clusters. All primary care and cardiology clinicians at participating clinics are included. The patient sample includes English- and Spanish-speaking CHD patients ≥21 years of age with screen-detected elevated depressive symptoms (ie, Patient Health Questionnaire-9 score ≥10) and a scheduled visit during the relevant time period. In the pre-implementation period, CHD patients receive usual care. At the start of each implementation period, a site's behavioral health providers (BHPs) and clinic administrators are invited to problem solving meetings; patients receive an eSDM and patient activation tool that includes psychoeducation, patient activation, and treatment selection support; and clinicians/BHPs receive a summary report of patients’ preferences &lt;em&gt;(implementation strategy)&lt;/em&gt;. During pre- and post-implementation periods, patients are assessed at baseline and 6 months for depressive symptoms, depression treatment intensification, health-related quality of life years, and (at baseline only) patient activation and decisional conflict. The primary effectiveness outcome is change in depressive symptoms from baseline to follow-up during the post-implementation period compared to pre-implementation period. Key trial design changes, relative to our initial pre-COVID-19 trial protocol, include transition from a stepped wedge design to a single pre- post design randomized to strategy timing, reduction of exclusion criteria, options to bypass clinicians for direct BHP referrals (vs reliance on referrals) and addressing multiplicity in our statistical analysis plan. The trial was launched in April 2019 and is estimated to conclude by July 2025.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Discussion&lt;/h3&gt;&lt;div&gt;The IHEART DEPCARE Trial is the first hybrid type II effectiveness-implementation trial to examine the effect of a brief, theory-informed eSDM and patient activation tool strategy on depression treatment uptake and symptoms in CHD patients. Our protocol advances the field of implementation science by incorporating a multilevel (vs single-level) implementation strategy to address depression, highlighting unique challenges ","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Pages 52-65"},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial
IF 3.7 2区 医学
American heart journal Pub Date : 2025-02-18 DOI: 10.1016/j.ahj.2025.02.010
Jeffrey M. Ashburner PhD, MPH , Reinier W.P. Tack MD , Shaan Khurshid MD, MPH , Ashby C. Turner MD , Steven J. Atlas MD, MPH , Daniel E. Singer MD , Patrick T. Ellinor MD, PhD , Emelia J. Benjamin MD, ScM , Ludovic Trinquart PhD , Steven A. Lubitz MD, MPH , Christopher D. Anderson MD, MMSc
{"title":"Impact of a clinical atrial fibrillation risk estimation tool on cardiac rhythm monitor utilization following acute ischemic stroke: A prepost clinical trial","authors":"Jeffrey M. Ashburner PhD, MPH ,&nbsp;Reinier W.P. Tack MD ,&nbsp;Shaan Khurshid MD, MPH ,&nbsp;Ashby C. Turner MD ,&nbsp;Steven J. Atlas MD, MPH ,&nbsp;Daniel E. Singer MD ,&nbsp;Patrick T. Ellinor MD, PhD ,&nbsp;Emelia J. Benjamin MD, ScM ,&nbsp;Ludovic Trinquart PhD ,&nbsp;Steven A. Lubitz MD, MPH ,&nbsp;Christopher D. Anderson MD, MMSc","doi":"10.1016/j.ahj.2025.02.010","DOIUrl":"10.1016/j.ahj.2025.02.010","url":null,"abstract":"<div><h3>Background</h3><div>Detection of undiagnosed atrial fibrillation (AF) after ischemic stroke through extended cardiac monitoring is important for preventing recurrent stroke. We evaluated whether a tool that displays clinically predicted AF risk to clinicians caring for stroke patients was associated with the use of extended cardiac monitoring.</div></div><div><h3>Methods</h3><div>We prospectively included hospitalized ischemic stroke patients without known AF in a preintervention (October 2018 - June 2019) and intervention period (March 11, 2021 - March 10, 2022). The intervention consisted of an electronic health record (EHR)-based best-practice advisory (BPA) alert which calculated and displayed 5-year risk of AF. We used a multivariable Fine and Gray model to test for an interaction between predicted AF risk and period (preintervention vs intervention) with regards to incidence of extended cardiac monitoring. We compared the incidence of extended cardiac monitoring within 6-months of discharge between periods, stratified by BPA completion.</div></div><div><h3>Results</h3><div>We included 805 patients: 493 in the preintervention cohort and 312 in the intervention cohort. In the intervention cohort, the BPA was completed for 180 (58%) patients. The association between predicted clinical risk of AF and incidence of 6-month extended cardiac monitoring was not different by time period (interaction HR = 1.00 [95% Confidence Interval (CI) 0.98; 1.02]). The intervention period was associated with an increased cumulative incidence of cardiac monitoring (adjusted HR = 1.32 [95% CI 1.03-1.69]).</div></div><div><h3>Conclusions</h3><div>An embedded EHR tool displaying predicted AF risk in a poststroke setting had limited clinician engagement and predicted risk was not associated with the use of extended cardiac monitoring.</div></div><div><h3>Clinical Trial Registration</h3><div>NCT04637087</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"284 ","pages":"Pages 57-66"},"PeriodicalIF":3.7,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143466758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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