American heart journal最新文献

{"title":"Absence of coronary artery disease in patients undergoing coronary imaging and association with amyloidosis: A Danish nationwide study","authors":"Navid Noory MD ,&nbsp;Oscar Westin MD, PhD ,&nbsp;Eva Havers Borgersen MD ,&nbsp;Charlotte Kragelund MD, PhD ,&nbsp;Jens Dahlgaard Hove MD, PhD ,&nbsp;Matthew S. Maurer MD ,&nbsp;Lars Køber MD, DMSc ,&nbsp;Finn Gustafsson MD, DMSc ,&nbsp;Emil Fosbøl MD","doi":"10.1016/j.ahj.2025.03.011","DOIUrl":"10.1016/j.ahj.2025.03.011","url":null,"abstract":"<div><div>This nationwide registry-based study in Denmark revealed a higher 10-year cumulative incidence of amyloidosis among 79,443 coronary artery disease-negative patients compared to matched controls, with an adjusted hazard ratio of 7.43 (95% CI 4.01-13.7). These findings warrant prospective studies to investigate the prevalence of amyloidosis in patients negative for coronary artery disease after coronary examination.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 75-79"},"PeriodicalIF":3.7,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742006","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}

{"title":"Corrigendum to “Days alive out of hospital in heart failure: Insights from the PARADIGM-HF and CHARM trials” [Am Heart J 241 (2021) 108-119]","authors":"Yiming Chen MS ,&nbsp;John Lawrence PhD ,&nbsp;Norman Stockbridge MD, PhD","doi":"10.1016/j.ahj.2025.03.007","DOIUrl":"10.1016/j.ahj.2025.03.007","url":null,"abstract":"","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"285 ","pages":"Page 105"},"PeriodicalIF":3.7,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143704537","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}

{"title":"Hyperoxemic oxygen therapy in patients with acute anterior myocardial infarction: HOT-AAMI—design and rationale of a randomized trial","authors":"Uwe Zeymer ,&nbsp;Fathema Hassinger ,&nbsp;Peter Bramlage ,&nbsp;Andreas Schafer ,&nbsp;Dirk Westermann ,&nbsp;Holger Thiele ,&nbsp;The HOT-AAMI Investigators","doi":"10.1016/j.ahj.2025.03.013","DOIUrl":"10.1016/j.ahj.2025.03.013","url":null,"abstract":"<div><h3>Background</h3><div>Patients with acute anterior ST-elevation myocardial infarction (STEMI) are at high risk for death and heart failure (HF) despite treatment with primary percutaneous coronary intervention (PCI). Adjunctive therapy with hyperoxemic supersaturated oxygen (SSO2) following PCI reduced infarct size in previous randomized trials, but none of these trials were powered for clinical endpoints.</div></div><div><h3>Aims</h3><div>The HOT-AAMI trial evaluates whether hyperoxemic supersaturated oxygen (SSO2) therapy following PCI reduces the risk of death and heart failure.</div></div><div><h3>Methods</h3><div>HOT-AAMI is a multicenter, 1:1 randomized, open-label study across 50 sites in Germany. Patients presenting with anterior STEMI and undergoing successful PCI of the left anterior descending artery are randomized to receive SSO2 therapy on top of standard care or standard of care alone. The primary endpoint is a composite of all-cause mortality or unplanned heart failure hospital admission or outpatient visit due to heart failure requiring intravenous diuretic therapy during 12-48 months follow-up. Secondary endpoints include cardiovascular mortality, recurrent myocardial infarction, stroke, and quality of life. The sample size calculation for the HOT-AAMI trial is based on detecting a relative reduction of 25% in the primary composite endpoint. In the control group, a yearly event rate of 16% is expected, comprised of mortality (7%), hospitalization for heart failure (5%), and acute heart failure requiring outpatient treatment (4%). The study is designed to detect this 25% relative difference with a 2-sided significance level of 0.05 and 80% power, requiring a total of 393 events; therefore 1,266 patients will be enrolled.</div></div><div><h3>Conclusions</h3><div>The HOT-AAMI trial is the first trial powered to determine whether SSO2 therapy, administered immediately post-PCI, improves death and heart failure outcomes in patients with anterior STEMI.</div></div><div><h3>Trial registration</h3><div>HOT-AAMI Clinicaltrials.gov NCT06742684.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 35-44"},"PeriodicalIF":3.7,"publicationDate":"2025-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690877","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}

{"title":"Association between vasopressin administration and mortality in patients with cardiogenic shock","authors":"Dhruv Sarma BMBCh ,&nbsp;Ryan Smith MD ,&nbsp;Mitchell Padkins MD ,&nbsp;Aniket S. Rali MD ,&nbsp;Saraschandra Vallabhajosyula MD, MSc ,&nbsp;Ashish K. Khanna MD, MS ,&nbsp;Kianoush Kashani MD ,&nbsp;Benjamin Hibbert MD ,&nbsp;Jacob C. Jentzer MD","doi":"10.1016/j.ahj.2025.03.009","DOIUrl":"10.1016/j.ahj.2025.03.009","url":null,"abstract":"<div><h3>Background</h3><div>The utility of vasopressin as an adjunctive, catecholamine-sparing vasopressor in cardiogenic shock (CS) has not been widely examined.</div></div><div><h3>Methods</h3><div>We included consecutive adult patients admitted with a diagnosis of CS requiring vasopressors. High-dose vasopressors (HDV) were defined as ≥0.3 mcg/kg/min of norepinephrine equivalent. Multivariable logistic regression and propensity analysis was used to calculate odds ratio (OR) and 95% confidence interval (CI) values for in-hospital mortality, before and after adjustment for relevant covariates.</div></div><div><h3>Results</h3><div>We included 721 CS patients, including HDV in 32.5%. Vasopressin was administered in 207 (29%) patients within the first 24 hours. In-hospital mortality occurred in 38.1% and was higher in the HDV group (56.8% vs 29.2%). Vasopressin was associated with lower propensity adjusted in-hospital mortality (adjusted OR 0.59, 95% CI, 0.35-0.99, <em>P</em> = .05). Vasopressin use was also associated with lower mortality in the HDV group (unadjusted OR 0.54, 95% CI, 0.32-0.92, <em>P</em> = .02).</div></div><div><h3>Conclusions</h3><div>Vasopressin use in the first 24 hours was associated with lower adjusted mortality in patients with CS, particularly amongst those requiring HDV. The use of vasopressin in CS merits dedicated prospective evaluation.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 88-96"},"PeriodicalIF":3.7,"publicationDate":"2025-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143690872","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}

{"title":"The 2024 think tank on prevention of sudden cardiac death in the young: Pathway to survival. A report from the cardiac safety research consortium","authors":"Jordan E. Ezekian MD, MPH ,&nbsp;Charles C. Anderson MD ,&nbsp;Peter F. Aziz MD ,&nbsp;Samia Baluch MS ,&nbsp;Stuart Berger MD ,&nbsp;Martha Lopez-Anderson BBA ,&nbsp;Vincent Miller MMCI ,&nbsp;Yoshihide Mitani MD, PhD ,&nbsp;Silvana Molossi MD, PhD ,&nbsp;Valarie Morrow MD ,&nbsp;Victoria L. Vetter MD, MPH ,&nbsp;Elizabeth Vickers Saarel MD ,&nbsp;Bhavya Trivedi MD, PhD ,&nbsp;Salim F. Idriss MD PhD ,&nbsp;2024 Think Tank participants","doi":"10.1016/j.ahj.2025.03.010","DOIUrl":"10.1016/j.ahj.2025.03.010","url":null,"abstract":"<div><div>Sudden cardiac arrest and death in the young is a critical public health issue. It occurs in children of any age, sex, racial or ethnic demographic, or socioeconomic status. Importantly, it can affect any individual—athlete and nonathlete alike. Prevention of sudden death in the young is of high importance not only because of the loss of a young life but also because of the substantial impact to families and to society at large. This White Paper summarizes the proceedings of a third national Think Tank on prevention of sudden cardiac death in the young. The Think Tank, which convened on January 11 to 12, 2024 at Duke University in Durham, NC, was organized and conducted by the Cardiac Safety Research Consortium in collaboration with a broad panel of US and international stakeholders including representatives from the United States Food and Drug Administration, medicine, academia, industry, the military, parents and sudden cardiac arrest/death prevention advocates, and the public. Primary and secondary prevention of sudden cardiac death in youth were discussed in depth with a goal of developing consensus on uniform approaches which could be applied nationally.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 45-55"},"PeriodicalIF":3.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143668708","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}

{"title":"Advancement of the implementation of evidence-based therapies for cardiovascular-kidney-metabolic conditions: A multi-stakeholder perspective","authors":"Nkiru Osude MD, MS ,&nbsp;Harriette Van Spall MD, MPH ,&nbsp;Hayden Bosworth PhD ,&nbsp;Konstantin Krychtiuk MD, PhD ,&nbsp;John Spertus MD ,&nbsp;Samuel Fatoba MPH ,&nbsp;Lee Fleisher MD ,&nbsp;Edward Fry MD ,&nbsp;Jennifer Green MD ,&nbsp;Stephen Greene MD ,&nbsp;Michael Ho MD, PhD ,&nbsp;Jennifer Jackman PhD ,&nbsp;Jane Leopold MD ,&nbsp;Melissa Magwire RN, MSN ,&nbsp;Darren McGuire MD, MHSc ,&nbsp;George Mensah MD ,&nbsp;Katherine R. Tuttle MD ,&nbsp;Vincent Willey PharmD ,&nbsp;Neha Pagidipati MD, MPH ,&nbsp;Christopher Granger MD","doi":"10.1016/j.ahj.2025.03.005","DOIUrl":"10.1016/j.ahj.2025.03.005","url":null,"abstract":"<div><div>Cardiovascular disease remains the leading cause of mortality and healthcare expenditures in the United States. It is also a major contributor to premature mortality, years lived with disability, and rising healthcare costs around the world. Despite the availability of proven therapies and interventions that could vastly decrease the burden of cardiovascular disease and cardiometabolic conditions, their implementation is poor, with generally less than half of patients being treated with the most effective therapies. Implementation science offers promise in bridging this gap and mitigating disparities. However, even though small studies have shown that there are effective methods to improve the implementation of evidence-based therapies, these methods have not been scaled to make an impact at the level of health systems or nationally. A coordinated, multi-stakeholder approach is essential to identify barriers to implementation on a broad scale and, more critically, to develop and deploy practical solutions. The Duke Clinical Research Institute conducted an Implementation Summit entitled “Scalability, Spread, and Sustainability” to explore strategies for advancing the uptake of evidence-based interventions for cardiometabolic diseases in healthcare in the United States. This manuscript presents the participants’ multi-stakeholder perspective on the steps necessary to improve the implementation of evidence-based therapies in cardiometabolic disease. Key recommendations include focused efforts on evidence generation around broad implementation strategies, dissemination of the evidence generated, uptake of evidence into usual care settings, and investment in training the current and next generations of leaders in implementation.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 18-34"},"PeriodicalIF":3.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662063","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}

{"title":"Cardiac auscultation skills among medical trainees","authors":"Neil S. Zhang MD, MS ,&nbsp;Joy Y. Yang PhD ,&nbsp;Joshua I. Goldhaber MD ,&nbsp;Binh An P. Phan MD ,&nbsp;Melvin D. Cheitlin MD","doi":"10.1016/j.ahj.2025.03.006","DOIUrl":"10.1016/j.ahj.2025.03.006","url":null,"abstract":"<div><h3>Background</h3><div>Many experts suspect there has been a gradual decline in cardiac auscultation skills among physicians, though no studies have examined this hypothesis over time. We sought to better evaluate the long-term change in medical trainees' cardiac auscultation skills.</div></div><div><h3>Methods</h3><div>We performed a repeated cross-sectional study to analyze medical trainee performance on a cardiac auscultation simulation test over an 11-year period. The simulation tests involved identifying pre-recorded heart sounds and murmurs. Test results were analyzed with linear regression to evaluate temporal trends in scores. Performance on individual heart sounds and murmurs was also analyzed.</div></div><div><h3>Results</h3><div>We included results from 411 simulation tests representing 348 medical students (84.7%), 37 residents (9.0%), and 26 cardiology fellows (6.3%). The overall average test score was 7.7 points (SD 2.5). Test scores declined over time for all trainees by 0.15 points per year (P=0.003). Fellows performed better than medical students by an average of 2.1 points (P &lt; 0.001), while residents performed better than medical students by an average of 1.1 points (P = 0.008). Overall performance on individual heartsounds and murmurs was variable with no significant change in performance over time.</div></div><div><h3>Conclusion</h3><div>Medical student trainees at an academic medical center had declining cardiac auscultation skills over time, with a possible similar decline noted among internal medicine residents and cardiology fellows. This study underscores the importance of broad investment in strategies for teaching cardiac auscultation to preserve and improve this essential skill.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 14-17"},"PeriodicalIF":3.7,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647000","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}

{"title":"Accuracy of Instantaneous Wave-free Ratio and Fractional Flow Reserve Derived From Single Coronary Angiographic Projections.","authors":"Yoshinobu Onuma, Kai Ninomiya, Krischan Sjauw, Peter Damman, Hitoshi Matsuo, Clemens von Birgelen, Emelyne Sevestre, Masafumi Ono, Neil O'Leary, Scot Garg, Martijn A van Lavieren, Becky Inderbitzen, Takashi Akasaka, Javier Escaned, Manesh R Patel, Patrick W Serruys","doi":"10.1016/j.ahj.2025.03.001","DOIUrl":"https://doi.org/10.1016/j.ahj.2025.03.001","url":null,"abstract":"<p><strong>Background: </strong>Angiography-derived Fractional Flow Reserve (FFR) software has been developed using pressure wire based FFR as the reference, however most software requires two angiographic views ≥25 degrees apart limiting their clinical utility. This study aims to validate in a prospective multi-center registry the diagnostic performance of a novel angiography derived instantaneous wave-free ratio (Angio-iFR, Royal Philips, Amsterdam) with pressure wire-based iFR as reference.</p><p><strong>Methods: </strong>Coronary angiograms were obtained from patients with coronary artery lesions of between 40-90% severity and both iFR and FFR measurements. The pressure wire's position was documented during contrast injection in two angiographic views. Angio-iFR/FFR was computed at this exact position by independent corelab analysts blinded to physiological data. The primary end point was the sensitivity and specificity of the Angio-iFR compared to the corresponding invasively measured iFR values. The study was powered to meet prespecified performance goals for sensitivity (75%) and specificity (80%).</p><p><strong>Results: </strong>A total of 441 patients were enrolled in 32 centers in Europe, Japan, and the United States. Paired Angio-iFR and wire-iFR were available in 398 vessels. The mean iFR was 0.90 (standard deviation: 0.11) with 31.9% of vessels having an iFR≤0.89. Angio-iFR software showed excellent feasibility (97%), and a median analysis time of 55 seconds. The per-vessel sensitivity and specificity of Angio-iFR was 77% (95% confidence interval [CI]: 69-84%) and 49% (95%CI: 41- 54%) respectively, which fell below the performance goals.</p><p><strong>Conclusions: </strong>Angio-iFR did not achieve prespecified diagnostic performance against pressure wire-based iFR. Further software refinements are warranted.</p><p><strong>Trial registration: </strong>Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR), NCT0385750, https://clinicaltrials.gov/study/NCT03857503.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623249","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}

{"title":"Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence-TIMI 73b trial.","authors":"Brian A Bergmark, Nicholas A Marston, Thomas A Prohaska, Veronica J Alexander, Andre Zimerman, Filipe A Moura, Yu Mi Kang, Sabina A Murphy, Shuanglu Zhang, Michael T Lu, Ewa Karwatowska-Prokopczuk, Sotirios Tsimikas, Robert P Giugliano, Marc S Sabatine","doi":"10.1016/j.ahj.2025.02.022","DOIUrl":"10.1016/j.ahj.2025.02.022","url":null,"abstract":"<p><strong>Background: </strong>Elevated triglycerides are an important risk factor for atherosclerosis. However, the magnitude of triglyceride lowering with currently available therapies is modest and the impact of triglyceride-lowering on atherosclerosis remains undefined. Olezarsen is an antisense oligonucleotide (ASO) targeting mRNA for apolipoprotein C-III (apoC-III), an inhibitor of triglyceride clearance.</p><p><strong>Methods: </strong>The Essence-TIMI 73b trial (NCT05610280) is a randomized, double-blind, placebo-controlled phase 3 trial of olezarsen 50 mg or 80 mg every 4 weeks compared with placebo. The trial enrolled adults with either moderate hypertriglyceridemia (200-499 mg/dL) plus increased cardiovascular risk, or severe hypertriglyceridemia (≥500 mg/dL). The primary endpoint is the percent change in triglyceride levels from baseline to 6 months, reported as the difference between each olezarsen dose group and pooled placebo. A coronary computed tomography angiography (CTA) substudy will examine changes in noncalcified plaque volume from baseline to 12 months.</p><p><strong>Results: </strong>A total of 1,478 patients were randomized at 160 sites in North America and Europe. The median age is 63 (IQR 56-69) years, 39% are women, and 71% are non-Hispanic White. Overall, 60% of patients have diabetes, and 42% have atherosclerotic cardiovascular disease. At randomization, 97% were receiving lipid-lowering therapies, including 82% on a statin. The median baseline triglyceride level was 249 (195-339) mg/dL and 9% of patients had triglycerides ≥500 mg/dL at enrollment. Approximately 1000 patients completed a baseline CTA, of whom 555 (55%) had measurable noncalcified coronary plaque and continued in the substudy.</p><p><strong>Discussion: </strong>Targeting apoC-III to facilitate clearance of triglyceride-rich lipoproteins is a potential therapeutic strategy for lowering triglyceride levels, regressing atherosclerosis, and reducing cardiovascular risk. The phase 3 Essence-TIMI 73b trial, which has enrolled nearly 1,500 patients, including over 550 in a coronary CTA substudy, should provide key insights into the efficacy and safety of olezarsen in patients with largely moderate hypertriglyceridemia and elevated cardiovascular risk.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: NCT05610280.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623250","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}

{"title":"Rationale and design of the TeleClinical Care Cardiac (TCC-Cardiac) trial: A pragmatic randomized trial of adjunctive virtual models of care in the secondary prevention of cardiovascular events","authors":"Jennifer Yu BSc, MBBS, PhD ,&nbsp;Praveen Indraratna MBBS, PhD ,&nbsp;Nancy E. Briggs MA, PhD ,&nbsp;Peter Brown BIT(Hons), PhD ,&nbsp;Hueiming Liu BA(Hons), MBBS, MIPH, PhD ,&nbsp;Emily R. Atkins BHlthSc(Hons1) PhD ,&nbsp;Matthew Allan MBBS ,&nbsp;Ben Lambert MBBS ,&nbsp;Chris Alexopoulos BSc, MBBS(Hons) ,&nbsp;Pratap Shetty MBBS, MD ,&nbsp;Craig Juergens MBBS DMedSc ,&nbsp;John French MBCHB, MSc, PhD ,&nbsp;Joshua Head BIT ,&nbsp;Bal Kaur BSc, BA, MIS ,&nbsp;Siaw-Teng Liaw PhD ,&nbsp;Gemma A. Figtree MBBS, DPhil ,&nbsp;Robyn Gallagher RN, PhD ,&nbsp;Guenter Shreier PhD ,&nbsp;Branko Celler BSc, BEE(Hons), PhD ,&nbsp;Stephen Jan BEc, MEc, PhD ,&nbsp;Sze-Yuan Ooi MBBS, MD","doi":"10.1016/j.ahj.2025.03.008","DOIUrl":"10.1016/j.ahj.2025.03.008","url":null,"abstract":"<div><h3>Background</h3><div>Digital health interventions have potential to improve outcomes in high risk cardiac patients through remote monitoring and patient education but introduce accessibility issues among patients who lack suitable smartphones. We will evaluate the effectiveness and scalability of the TeleClinical Care Cardiac (TCC<img>Cardiac) platform, that aims to reduce hospital readmissions and improve adherence to care.</div></div><div><h3>Methods</h3><div>A pragmatic, all-comers trial with nested randomization, where patients being discharged home following an admission with acute myocardial infarction (MI) or decompensated heart failure (HF) are divided into 3 cohorts pragmatically, based on their access to technology. Cohort 1 participants are randomized to either the TCC<img>Cardiac model of care or usual care alone. The intervention includes a smartphone app, blood pressure monitor, weight scales, and a pulse oximeter, with remote monitoring of daily inputs by clinicians. Cohort 2 participants, with incompatible mobile phones, are randomized to receive educational content by SMS (TCC-Text) or usual care alone. Cohort 3 participants with no mobile phone receive usual care alone. The primary objective is to compare six-month readmission rates (primary end point) in Cohort 1. Secondary objectives include comparing the primary end point, evaluating the cost-effectiveness and overall impact across all cohorts and interventions, and process evaluation to understand the reach, adoption, and effectiveness of the full intervention. Follow-up includes 6-month interview for Cohort 1 and data linkage for all cohorts for 12-month outcomes.</div></div><div><h3>Results</h3><div>The trial began in July 2021. Recruitment was slower than expected due to delays and interruptions related to COVID-19 and the final enrolment date was set for October 2023, by which time 873 participants had been enrolled: 553 in Cohort 1 (63.3%), 161 in Cohort 2 (18.4%), and 159 in Cohort 3 (18.2%). Data linkage is anticipated in May 2025, which includes a 6-month delay to ensure 12-month data will be available for all study patients, followed by the analysis of results.</div></div><div><h3>Conclusions</h3><div>TCC<img>Cardiac is the first large-scale study to assess smartphone-based messaging and remote monitoring in high-risk cardiac patients post-hospitalization. The study's pragmatic design and process evaluation aim to enhance future implementation.</div></div><div><h3>Trial Registration</h3><div>Australian New Zealand Clinical Trials Registry Number ACTRN12621000754842.</div></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"286 ","pages":"Pages 56-65"},"PeriodicalIF":3.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623251","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}