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Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial—rationale and design 与安慰剂相比,秋水仙碱对稳定型冠状动脉疾病患者已知冠状动脉粥样硬化进展的影响(EKSTROM)试验--原理与设计。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-07-17 DOI: 10.1016/j.ahj.2024.07.005
Dhiran Verghese MD , Sajad Hamal MS , Ahmed Ghanem MD , April Kinninger MPH , Denise Javier MD , Keshi Ichikawa MD , Travis Benzing MD , Srikanth Krishnan MD , Sina Kianoush MD , Hossein Hamidi MD , Marziyeh Bagheri MD , Divya Abraham MD , Mina Deljavanghodrati MD , Ayesha Ghoto MD , Jairo Aldana-Bitar MD , Matthew Budoff MD
{"title":"Effect of colchicine on progression of known coronary atherosclerosis in patients with STable CoROnary artery disease CoMpared to placebo (EKSTROM) trial—rationale and design","authors":"Dhiran Verghese MD ,&nbsp;Sajad Hamal MS ,&nbsp;Ahmed Ghanem MD ,&nbsp;April Kinninger MPH ,&nbsp;Denise Javier MD ,&nbsp;Keshi Ichikawa MD ,&nbsp;Travis Benzing MD ,&nbsp;Srikanth Krishnan MD ,&nbsp;Sina Kianoush MD ,&nbsp;Hossein Hamidi MD ,&nbsp;Marziyeh Bagheri MD ,&nbsp;Divya Abraham MD ,&nbsp;Mina Deljavanghodrati MD ,&nbsp;Ayesha Ghoto MD ,&nbsp;Jairo Aldana-Bitar MD ,&nbsp;Matthew Budoff MD","doi":"10.1016/j.ahj.2024.07.005","DOIUrl":"10.1016/j.ahj.2024.07.005","url":null,"abstract":"<div><h3>Background</h3><p>Cardiovascular disease is the major cause of mortality in the United States. Despite lifestyle modification and traditional risk factor control residual inflammatory risk remains an untreated concern. Colchicine is an oral, medication that has been used for gout, mediterranean fever and pericarditis for decades. In recent trials, colchicine has been shown to reduce major adverse cardiovascular events, however the mechanism of benefit remains unclear. The objective of the randomized, double-blind, placebo controlled EKSTROM trial is to evaluate the effects of colchicine 0.5mg/day on atherosclerotic plaque.</p></div><div><h3>Methods</h3><p>Eighty-four participants will be enrolled after obtaining informed consent and followed for 12 months. Eligible patients will be randomly assigned to colchicine 0.5mg/day or placebo in a 1:1 fashion as add-on to their standard of care. All participants will undergo coronary computed tomography angiography (CCTA) at baseline and at 12 months.</p></div><div><h3>Results</h3><p>As of November 2023, the study is 100% enrolled with an expected end of study by the second quarter of 2024. The primary endpoint is change in low attenuation plaque volume as measured by CCTA. Secondary endpoints include change in volume of different plaque types (including total atheroma volume, noncalcified plaque volume, dense calcified plaque volume, remodeling index), change in inflammatory markers (IL-6, IL-1β, IL-18, hs-CRP), change in pericoronary adipose tissue attenuation, change in epicardial adipose tissue volume and attenuation and change in brachial flow mediated dilation.</p></div><div><h3>Conclusion</h3><p>EKSTROM is the first randomized study to assess the effects of colchicine on plaque progression, pericoronary and epicardial fat. EKSTROM will provide important information on the mechanistic effects of colchicine on the cardiovascular system.</p></div><div><h3>Trial registration</h3><p>Registry: clinicaltrials.gov, Registration Number: NCT06342609 url: https://www.clinicaltrials.gov/study/NCT06342609?term=EKSTROM&amp;rank=1</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 20-26"},"PeriodicalIF":3.7,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141726803","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
Race, hypertensive disorders of pregnancy and outcomes in peripartum cardiomyopathy 种族、妊娠期高血压疾病与围产期心肌病的预后。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-07-10 DOI: 10.1016/j.ahj.2024.07.002
{"title":"Race, hypertensive disorders of pregnancy and outcomes in peripartum cardiomyopathy","authors":"","doi":"10.1016/j.ahj.2024.07.002","DOIUrl":"10.1016/j.ahj.2024.07.002","url":null,"abstract":"<div><h3>Background</h3><p>Black women with peripartum cardiomyopathy (PPCM) have a higher prevalence of hypertensive disorders of pregnancy (HDP) and worse clinical outcomes compared with non-Black women. We examined the impact of HDP on myocardial recovery in Black women with PPCM.</p></div><div><h3>Methods</h3><p>A total of 100 women were enrolled into the Investigation in Pregnancy Associated Cardiomyopathy (IPAC) study. Left ventricular ejection fraction (LVEF) was assessed by echocardiography at entry, 6, and 12-months post-partum (PP). Women were followed for 12 months postpartum and outcomes including persistent cardiomyopathy (LVEF ≤35%), left ventricular assist device, (LVAD), cardiac transplantation, or death were examined in subsets based on race and the presence of HDP.</p></div><div><h3>Results</h3><p>Black women with HDP were more likely to present earlier compared to Black women without HDP (days PP HDP: 34 ± 21 vs 54 ± 27 days, <em>P</em> = .03). There was no difference in LVEF at study entry for Black women based on HDP, but better recovery with HDP at 6 (HDP: 52 <em>±</em> 11% vs no HDP: 40 ± 14%, <em>P</em> = .03) and 12-months (HDP:53 ± 10% vs no HDP:40 ± 16%, <em>P</em> = .02). At 12-months, Black women overall had a lower LVEF than non-Black women (<em>P</em> &lt; .001), driven by less recovery in Black women without HDP compared to non-Black women (<em>P</em> &lt; .001). In contrast, Black women with HDP had a similar LVEF at 12 months compared to non-Black women (<em>P</em> = .56).</p></div><div><h3>Conclusions</h3><p>In women with PPCM, poorer outcomes evident in Black women were driven by women without a history of HDP. In Black women, a history of HDP was associated with earlier presentation and recovery which was comparable to non-Black women.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"276 ","pages":"Pages 60-69"},"PeriodicalIF":3.7,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141598161","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
Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry. 美国成年人低密度脂蛋白胆固醇<55毫克/分升的达标情况:cvMOBIUS2登记的结果。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-07-06 DOI: 10.1016/j.ahj.2024.06.012
Ann Marie Navar, Nishant P Shah, Peter Shrader, Laine E Thomas, Zahid Ahmad, Clint Allred, Alanna M Chamberlain, Elizabeth A Chrischilles, Nafeesa Dhalwani, Mark B Effron, Salim Hayek, Laney K Jones, Bethany Kalich, Michael D Shapiro, Cezary Wójcik, Eric D Peterson
{"title":"Achievement of LDL-C <55 mg/dL among US adults: Findings from the cvMOBIUS2 registry.","authors":"Ann Marie Navar, Nishant P Shah, Peter Shrader, Laine E Thomas, Zahid Ahmad, Clint Allred, Alanna M Chamberlain, Elizabeth A Chrischilles, Nafeesa Dhalwani, Mark B Effron, Salim Hayek, Laney K Jones, Bethany Kalich, Michael D Shapiro, Cezary Wójcik, Eric D Peterson","doi":"10.1016/j.ahj.2024.06.012","DOIUrl":"10.1016/j.ahj.2024.06.012","url":null,"abstract":"<p><strong>Background: </strong>Reflecting clinical trial data showing improved outcomes with lower LDL-C levels, guidelines across the globe are increasingly recommending a goal of LDL-C <55 mg/dL in persons with atherosclerotic cardiovascular disease (ASCVD). What proportion of patients with ASCVD are already meeting those goals in the US remains understudied.</p><p><strong>Methods: </strong>Using electronic health record data from 8 large US health systems, we evaluated lipid-lowering therapy (LLT), LDL-C levels, and factors associated with an LDL-C <55 mg/dL in persons with ASCVD treated between 1/1/2021-12/31/2021. Multivariable modeling was used to evaluate factors associated with achievement of an LDL-C <55 mg/dL.</p><p><strong>Results: </strong>Among 167,899 eligible patients, 22.6% (38,016) had an LDL-C <55 mg/dL. While 76.1% of individuals overall were on a statin, only 38.2% were on a high-intensity statin, 5.9% were on ezetimibe, and 1.7% were on a PCSK9i monoclonal antibody (mAb). Factors associated with lower likelihood of achieving an LDL-C <55 mg/dL included: younger age (odds ratio [OR] 0.91 per 10y), female sex (OR 0.69), Black race (OR 0.76), and noncoronary artery disease forms of ASCVD including peripheral artery disease (OR 0.72) and cerebrovascular disease (OR 0.85), while high-intensity statin use was associated with increased odds of LDL-C <55 mg/dL (OR 1.55). Combination therapy (statin+ezetimibe or statin+PCSK9i mAb) was rare (4.4% and 0.5%, respectively) and was associated with higher odds of an LDL-C <55 mg/dL (OR 1.39 and 3.13, respectively).</p><p><strong>Conclusion: </strong>Less than a quarter of US patients with ASCVD in community practice are already achieving an LDL-C <55 mg/dL. Marked increases in utilization of both high intensity statins and combination therapy with non-statin therapy will be needed to achieve LDL-C levels <55 mg/dL at the population level in secondary prevention.</p>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554066","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
Nocturnal hypoxemic burden in patients with heart failure: Emerging prognostic role of its nonspecific component 心力衰竭患者的夜间低氧血症负担:非特异性成分的新预后作用
IF 3.7 2区 医学
American heart journal Pub Date : 2024-07-06 DOI: 10.1016/j.ahj.2024.06.011
{"title":"Nocturnal hypoxemic burden in patients with heart failure: Emerging prognostic role of its nonspecific component","authors":"","doi":"10.1016/j.ahj.2024.06.011","DOIUrl":"10.1016/j.ahj.2024.06.011","url":null,"abstract":"<div><h3>Background</h3><p>Nocturnal hypoxemic burden has been shown to be a robust, independent predictor of all-cause mortality in patients with heart failure and reduced ejection fraction (HFrEF) and to occur in a severe form even in patients with low or negligible frequency of respiratory events (apneas/hypopneas). This suggests the existence of two components of hypoxemic burden: one unrelated to respiratory events and the other related. The aim of this study was to characterize these two components and to evaluate their prognostic value.</p></div><div><h3>Methods</h3><p>Nocturnal hypoxemic burden was assessed in a cohort of 280 patients with HFrEF by measuring the percentage of sleep with an oxygen saturation (SpO<sub>2</sub>) &lt;90% (T90), and the area of the SpO<sub>2</sub> curve below 90% (Area90). Both indices were also recalculated within the sleep segments associated with respiratory events (event-related component: T90<sub>Eve</sub>, Area90<sub>Eve</sub>) and outside these segments (nonspecific component: T90<sub>Nspec</sub>, Area90<sub>Nspec</sub>). The outcome of the survival analysis (Cox regression) was all-cause mortality.</p></div><div><h3>Results</h3><p>During a median follow-up of 60 months, 87 patients died. T90, Area90, and their components were significant in univariate analysis (<em>P</em> &lt; .05 all). However, when these indices were adjusted for known risk factors, T90, T90<sub>Nspec</sub>, Area90, and Area90<sub>Nspec</sub> remained statistically significant (<em>P = .</em>018, hazard ratio (HR)=1.12, 95%CI=(1.02, 1.23); <em>P = .</em>007, HR=1.20, 95% CI = [1.05, 1.37]; <em>P</em> = .020, HR = 1.05, 95% CI = [1.01, 1.10]; <em>P</em> = .0006, HR = 1.15, 95% CI = [1.06, 1.25]), whereas T90<sub>Eve</sub> and Area90<sub>Eve</sub> did not (<em>P</em> = .27, <em>P</em> = .28). These results were internally validated using bootstrap resampling.</p></div><div><h3>Conclusions</h3><p>By demonstrating a significant independent association of nonspecific hypoxemic burden with all-cause mortality, this study suggests that this component of total nocturnal hypoxemic burden may play an important prognostic role in patients with HFrEF.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"276 ","pages":"Pages 1-11"},"PeriodicalIF":3.7,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141554067","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
Characterization of peripheral artery disease and associations with traditional risk factors, mobility, and biomarkers in the project baseline health study 健康基线项目研究》中外周动脉疾病的特征以及与传统风险因素、流动性和生物标志物的关联。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-07-03 DOI: 10.1016/j.ahj.2024.06.010
{"title":"Characterization of peripheral artery disease and associations with traditional risk factors, mobility, and biomarkers in the project baseline health study","authors":"","doi":"10.1016/j.ahj.2024.06.010","DOIUrl":"10.1016/j.ahj.2024.06.010","url":null,"abstract":"<div><h3>Background</h3><p>There is a dearth of research on immunophenotyping<span> in peripheral artery disease<span> (PAD). This study aimed to describe the baseline characteristics, immunophenotypic profile, and quality of life (QoL) of participants with PAD in the Project Baseline Health Study (PBHS).</span></span></p></div><div><h3>Methods</h3><p><span>The PBHS study is a prospective, multicenter, longitudinal cohort study that collected clinical, molecular, and </span>biometric data from participants recruited between 2017 and 2018. In this analysis, baseline demographic, clinical, mobility, QoL, and flow cytometry data were stratified by the presence of PAD (ankle brachial index [ABI] ≤0.90).</p></div><div><h3>Results</h3><p>Of 2,209 participants, 58 (2.6%) had lower-extremity PAD, and only 2 (3.4%) had pre-existing PAD diagnosed prior to enrollment. Comorbid smoking (29.3% vs 14%, <em>P</em> &lt; .001), hypertension (54% vs 30%, <em>P</em> &lt; .001), diabetes (25% vs 14%, <em>P =</em> .031), and at least moderate coronary calcifications (Agatston score &gt;100: 32% vs 17%, <em>P =</em> .01) were significantly higher in participants with PAD than in those with normal ABIs, as were high-sensitivity C-reactive protein levels (5.86 vs 2.83, <em>P</em><span> &lt; .001). After adjusting for demographic and risk factors, participants with PAD had significantly fewer circulating CD56-high natural killer cells<span>, IgM+ memory B cells, and CD10/CD27 double-positive B cells (</span></span><em>P</em> &lt; .05 for all).</p></div><div><h3>Conclusions</h3><p>This study reinforces existing evidence that a large proportion of PAD without claudication may be underdiagnosed, particularly in female and Black or African American participants. We describe a novel immunophenotypic profile of participants with PAD that could represent a potential future screening or diagnostic tool to facilitate earlier diagnosis of PAD.</p></div><div><h3>ClinicalTrials.gov Identifier</h3><p>NCT03154346, <span><span>https://clinicaltrials.gov/ct2/show/NCT03154346</span><svg><path></path></svg></span></p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"275 ","pages":"Pages 183-190"},"PeriodicalIF":3.7,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141537440","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
Electronic physician notification to facilitate the recognition and management of severe aortic stenosis: Rationale, design, and methods of the randomized controlled DETECT AS trial A44002PZS 电子医生通知以促进严重主动脉瓣狭窄的识别和管理:随机对照 DETECT AS 试验的原理、设计和方法。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-06-29 DOI: 10.1016/j.ahj.2024.06.009
{"title":"Electronic physician notification to facilitate the recognition and management of severe aortic stenosis: Rationale, design, and methods of the randomized controlled DETECT AS trial","authors":"","doi":"10.1016/j.ahj.2024.06.009","DOIUrl":"10.1016/j.ahj.2024.06.009","url":null,"abstract":"<div><h3>Background</h3><p>Symptomatic severe aortic stenosis causes substantial morbidity and mortality when left untreated, yet recent data suggest its undertreatment.</p></div><div><h3>Objective</h3><p>To evaluate the efficacy of electronic physician notification to facilitate the guideline-directed management of patients with severe aortic stenosis.</p></div><div><h3>Hypothesis</h3><p>We hypothesize that patients with severe aortic stenosis who are in the care of physicians who receive the notification are more likely to undergo aortic valve replacement within one year.</p></div><div><h3>Methods/Design</h3><p>The Electronic Physician Notification to Facilitate the Recognition and Management of Severe Aortic Stenosis (DETECT AS) trial is a randomized controlled trial and quality improvement initiative designed to evaluate the efficacy of electronic provider notification versus usual clinical care in the management of patients with severe aortic stenosis. Providers ordering an echocardiogram with findings potentially indicative of severe aortic stenosis are randomized to receive electronic notification with customized guideline recommendations for the management of severe aortic stenosis or usual care (no notification). Randomization continues until 940 patients are enrolled.</p></div><div><h3>Setting</h3><p>Multicentered, academic health system.</p></div><div><h3>Outcomes</h3><p>The primary endpoint is the proportion of patients with severe aortic stenosis receiving an aortic valve replacement within one year of the index echocardiogram. Secondary endpoints include mortality, heart failure hospitalization, transthoracic echocardiogram utilization, aortic stenosis billing code, and cardiology/Valve Team referral.</p></div><div><h3>Conclusion</h3><p>The DETECT AS trial will provide insight into whether electronic notification of providers on the presence of severe aortic stenosis and associated clinical guideline recommendations will facilitate recognition and guideline-directed management of severe aortic stenosis.</p></div><div><h3>Trial Registration</h3><p>ClinicalTrials.gov, NCT05230225, <span><span>https://clinicaltrials.gov/ct2/show/NCT05230225</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"276 ","pages":"Pages 39-48"},"PeriodicalIF":3.7,"publicationDate":"2024-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141475706","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
PCSK9 inhibitor added to high-intensity statin therapy to prevent cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention: a randomized, double- blind, placebo-controlled, multicenter SHAWN study 经皮冠状动脉介入治疗后急性冠状动脉综合征患者在高强度他汀治疗基础上加用 PCSK9 抑制剂预防心血管事件:随机、双盲、安慰剂对照、多中心 SHAWN 研究。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-06-27 DOI: 10.1016/j.ahj.2024.06.004
{"title":"PCSK9 inhibitor added to high-intensity statin therapy to prevent cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention: a randomized, double- blind, placebo-controlled, multicenter SHAWN study","authors":"","doi":"10.1016/j.ahj.2024.06.004","DOIUrl":"10.1016/j.ahj.2024.06.004","url":null,"abstract":"<div><h3>Background</h3><p>It is currently uncertain whether the combination of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor and high-intensity statin treatment can effectively reduce cardiovascular events in patients with acute coronary syndrome (ACS) who have undergone percutaneous coronary intervention (PCI) for culprit lesions.</p></div><div><h3>Methods</h3><p>This study protocol describes a double-blind, randomized, placebo-controlled, multicenter study aiming to investigate the efficacy and safety of combining a PCSK9 inhibitor with high-intensity statin therapy in patients with ACS following PCI. A total of 1,212 patients with ACS and multiple lesions will be enrolled and randomly assigned to receive either PCSK9 inhibitor plus high-intensity statin therapy or high-intensity statin monotherapy. The randomization process will be stratified by sites, diabetes, initial presentation and use of stable (≥4 weeks) statin treatment at presentation. PCSK 9 inhibitor or its placebo is injected within 4 hours after PCI for the culprit lesion. The primary endpoint is the composite of cardiovascular death, myocardial infarction, stroke, re-hospitalization due to ACS or heart failure, or any ischemia-driven coronary revascularization at 1-year follow-up between 2 groups. Safety endpoints mean PCSK 9 inhibitor and statin intolerance.</p></div><div><h3>Conclusion</h3><p>The SHAWN study has been specifically designed to evaluate the effectiveness and safety of adding a PCSK9 inhibitor to high-intensity statin therapy in patients who have experienced ACS following PCI. The primary objective of this study is to generate new evidence regarding the potential benefits of combining a PCSK9 inhibitor with high-intensity statin treatment in reducing cardiovascular events among these patients.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"277 ","pages":"Pages 58-65"},"PeriodicalIF":3.7,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465635","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
Restoring microvascular circulation with diagnostic ultrasound and contrast agent: rationale and design of the REDUCE trial 利用超声诊断和造影剂恢复微血管循环:REDUCE 试验的原理和设计。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-06-27 DOI: 10.1016/j.ahj.2024.06.008
{"title":"Restoring microvascular circulation with diagnostic ultrasound and contrast agent: rationale and design of the REDUCE trial","authors":"","doi":"10.1016/j.ahj.2024.06.008","DOIUrl":"10.1016/j.ahj.2024.06.008","url":null,"abstract":"<div><h3>Objectives</h3><p>This study aims to evaluate the efficacy and cost-effectiveness of sonothrombolysis delivered pre and post primary percutaneous coronary intervention (pPCI) on infarct size assessed by cardiac MRI, in patients presenting with STEMI, when compared against sham procedure.</p></div><div><h3>Background</h3><p>More than a half of patients with successful pPCI have significant microvascular obstruction and residual infarction. Sonothrombolysis is a therapeutic use of ultrasound with contrast enhancement that may improve microcirculation and infarct size. The benefits and real time physiological effects of sonothrombolysis in a multicentre setting are unclear.</p></div><div><h3>Methods</h3><p>The REDUCE (Restoring microvascular circulation with diagnostic ultrasound and contrast agent) trial is a prospective, multicentre, patient and outcome blinded, sham-controlled trial. Patients presenting with STEMI will be randomized to one of 2 treatment arms, to receive either sonothrombolysis treatment or sham echocardiography before and after pPCI. This tailored design is based on preliminary pilot data from our centre, showing that sonothrombolysis can be safely delivered, without prolonging door to balloon time. Our primary endpoint will be infarct size assessed on day 4±2 on Cardiac Magnetic Resonance (CMR). Patients will be followed up for 6 months post pPCI to assess secondary endpoints. Sample size calculations indicate we will need 150 patients recruited in total.</p></div><div><h3>Conclusions</h3><p>This multicentre trial will test whether sonothrombolysis delivered pre and post primary PCI can improve patient outcomes and is cost-effective, when compared with sham ultrasound delivered with primary PCI. The results from this trial may provide evidence for the utilization of sonothrombolysis as an adjunct therapy to pPCI to improve cardiovascular outcomes in STEMI. ANZ Clinical Trial Registration number: ACTRN 12620000807954</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"275 ","pages":"Pages 163-172"},"PeriodicalIF":3.7,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001625/pdfft?md5=8fdc72e6cfac55455c5a8d7aa2aba0dd&pid=1-s2.0-S0002870324001625-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465636","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
Decreased postpartum exercise capacity after a diagnosis of pre-eclampsia: Implications for CVD risk prediction 先兆子痫诊断后产后运动能力下降:对心血管疾病风险预测的影响。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-06-27 DOI: 10.1016/j.ahj.2024.06.002
{"title":"Decreased postpartum exercise capacity after a diagnosis of pre-eclampsia: Implications for CVD risk prediction","authors":"","doi":"10.1016/j.ahj.2024.06.002","DOIUrl":"10.1016/j.ahj.2024.06.002","url":null,"abstract":"<div><h3>Background</h3><p>Hypertensive disorders of pregnancy (HDP) are associated with increased long-term risk for cardiometabolic risk factors (chronic hypertension [HTN], obesity, diabetes) and heart failure. Exercise capacity is a known predictor of heart failure in patients with normal resting cardiac filling pressures. In this prospective observational cohort study, we sought to identify predictors of reduced postpartum exercise capacity in participants with normotensive vs preeclamptic pregnancies.</p></div><div><h3>Methods</h3><p>Preeclampsia (PreE) and normotensive subjects were enrolled to undergo bedside echocardiography within 48 hours of delivery, and rest/exercise echocardiography 12 weeks postpartum.</p></div><div><h3>Results</h3><p>Recruited subjects (n = 68) were grouped according to their blood pressure as: a) normotensive pregnancy n = 15; b) PreE with normotensive postpartum (PreE-Resolved, n = 36); c) PreE with persistent postpartum HTN (PreE-HTN, n = 17). At enrollment, a significantly higher percentage of subjects in the PreE-HTN group were Black. Compared to normotensive and PreE-Resolved subjects, those with PreE-HTN demonstrated higher resting systolic blood pressure (SBP, 112 [normotensive] vs 112 [PreE-Resolved] vs 134 [PreE-HTN], <em>P</em> &lt; .001) and diastolic blood pressure (DBP, 70.0 vs 72.5 vs 85.0, <em>P</em> &lt; .001), and significantly less postpartum weight loss (9.6% vs 13.6% vs 3.8%, <em>P</em> &lt; .001). Following Bruce protocol stress testing, PreE-HTN subjects demonstrated achieved significantly lower exercise duration (10.4 vs 10.2 vs 7.9 minutes, <em>P</em> = .001). Subjects with PreE-HTN also demonstrated evidence of exercise-induced diastolic dysfunction as assessed by peak exercise lateral e’ (18.0 vs 18.0 vs 13.5, <em>P</em> = .045) and peak exercise tricuspid regurgitation velocity (TR Vm, 2.4 vs 3.0 vs 3.1, <em>P</em> = 0.045). Exercise duration was negatively associated with gravidity (R = −0.27, <em>P</em> = .029) and postpartum LV mass index (R = −0.45, <em>P</em> &lt; .001), resting average E/e’ (R = −0.51, <em>P</em> &lt; .001), BMI (R = −0.6, <em>P</em> &lt; .001) and resting SBP (R = −0.51, <em>P</em> &lt; .001).</p></div><div><h3>Conclusions</h3><p>Postpartum exercise stress testing capacity is related to readily available clinical markers including pregnancy factors, echocardiographic parameters and unresolved cardiometabolic risk factors.</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"275 ","pages":"Pages 192-199"},"PeriodicalIF":3.7,"publicationDate":"2024-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465633","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
Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction CLEAR SYNERGY(OASIS 9)试验的设计与原理:心肌梗塞患者服用秋水仙碱与安慰剂、螺内酯与安慰剂的 2x2 因式随机对照试验。
IF 3.7 2区 医学
American heart journal Pub Date : 2024-06-25 DOI: 10.1016/j.ahj.2024.06.007
{"title":"Design and rationale of the CLEAR SYNERGY (OASIS 9) trial: A 2x2 factorial randomized controlled trial of colchicine versus placebo and spironolactone vs placebo in patients with myocardial infarction","authors":"","doi":"10.1016/j.ahj.2024.06.007","DOIUrl":"10.1016/j.ahj.2024.06.007","url":null,"abstract":"<div><h3>Background</h3><p>Patients experiencing myocardial infarction (MI) remain at high risk of future major adverse cardiovascular events (MACE). While low-dose colchicine and spironolactone have been shown to decrease post-MI MACE, more data are required to confirm their safety and efficacy in an unselected post-MI population. Therefore, we initiated the CLEAR SYNERGY (OASIS 9) trial to address these uncertainties.</p></div><div><h3>Methods</h3><p>The CLEAR SYNERGY trial is a 2 × 2 factorial randomized controlled trial of low-dose colchicine 0.5 mg daily versus placebo and spironolactone 25 mg daily versus placebo in 7,062 post-MI participants who were within 72 hours of the index percutaneous coronary intervention (PCI). We blinded participants, healthcare providers, research personnel, and outcome adjudicators to treatment allocation. The primary outcome for colchicine is the first occurrence of the composite of cardiovascular death, recurrent MI, stroke, or unplanned ischemia-driven revascularization. The coprimary outcomes for spironolactone are (1) the composite of the total numbers of cardiovascular death or new or worsening heart failure and (2) the first occurrence of the composite of cardiovascular death, new or worsening heart failure, recurrent MI or stroke. We finished recruitment with 7,062 participants from 104 centers in 14 countries on November 8, 2022, and plan to present the results in the fall of 2024.</p></div><div><h3>Conclusions</h3><p>CLEAR SYNERGY is a large international randomized controlled trial that will inform the effects of low-dose colchicine and spironolactone in largely unselected post-MI patients who undergo PCI. (ClinicalTrials.gov Identifier: NCT03048825).</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"275 ","pages":"Pages 173-182"},"PeriodicalIF":3.7,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0002870324001613/pdfft?md5=b8496797364593442846625c3a15024e&pid=1-s2.0-S0002870324001613-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141465634","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
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