Data Coordinating Center for VEST and PREDICTS

VEST 和 PREDICTS 数据协调中心

• 批准号: 7849017
• 负责人: Mark J Pletcher
• 金额: $ 61.63万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7849017
• 关键词: Address; Baroreflex; Biological; Blinded; Cause of Death; Cessation of life; Clinical; Clinical Data; Clinical Trials Data Monitoring Committees; Cohort Studies; Core Facility; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Data Set; Databases; Defibrillators; Documentation; EFRAC; Electric Countershock; Event; Funding; Future; Guidelines; Holter Electrocardiography; Implantable Defibrillators; Industry; Intervention; Leadership; Left; Left Ventricular Dysfunction; Left Ventricular Ejection Fraction; Link; Manuals; Methods; Modeling; Monitor; Multicenter Studies; Myocardial Infarction; National Heart, Lung, and Blood Institute; Outcome; Participant; Patients; Policies; Prevention; Primary Prevention; Procedures; Publications; Quality Control; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research Personnel; Risk; Sampling; Secure; Shock; Site; Stratification; Sudden Death; System; Tachycardia; Testing; Training; Ventricular Arrhythmia; Work; adjudicate; cost; data management; design; follow-up; high risk; high standard; implantation; meetings; mortality; operation; programs; randomized trial; tool

DESCRIPTION (provided by applicant): Despite the high rate of sudden death in the first 2 months following a myocardial infarction (Ml), current guidelines for implantable cardioverter defibrillators (ICDs) recommend delayed implantation (>40 days) after an Ml in patients with low ejection fraction (EF). Delaying implantation leaves an unprotected window of increased sudden death risk prior to ICD implantation. In addition, only left ventricular ejection fraction (EF) is used to decide whether a post-Mi patient should subsequently receive an ICD for primary prevention of sudden death. In this setting, only 20% of patients will have spontaneous ventricular arrhythmias requiring ICD shocks in the next 5 years. A more cost-effective method for selecting patients for primary prevention ICD implantation is needed. To address these two deficiencies, we propose the Vest prevention of Early Sudden death Trial (VEST) and the PREDiction of ICd Therapies Study (PREDICTS). This proposal seeks funding for a Clinical Coordinating Center, the linked R01 (PI Hulley) is for a Data Coordinating Center, and the remaining funding (80%) will come from industry. VEST is a multicenter, randomized, controlled trial to determine whether a non-invasive wearable defibrillator vest will reduce overall mortality during the first 60 days following an Ml in patients with left ventricular dysfunction (EF<35%). PREDICTS is a follow-up to this randomized intervention, in which participants in VEST will undergo a battery of risk stratification tests including T wave alternans, baroreflex sensitivity, Holter monitoring and 7 other likely predictors before placement of an ICD. Participants will then be monitored for ICD shocks and other clinical outcomes over the next 5 years. These data will be used to develop and validate a multivariable risk stratification tool that predicts the occurrence of "shockable" ventricular arrhythmias and efficiently identifies high-risk patients in whom an ICD would be most cost-effective (and low-risk patients in whom an ICD is not necessary). Biological samples and data from both studies will be stored and made available to outside investigators for future studies. We anticipate that VEST and PREDICTS will have a major impact on the 500,000 annual sudden deaths in the US by testing an intervention that may protect the very highest-risk early post-Mi patients, and by identifying a risk stratification strategy to identify those at highest and lowest risk and make ICD implantation more cost-effective.

描述（由申请人提供）：尽管在心肌梗塞后的前2个月内猝死率很高，但在低屈服分数（EF）患者的ML后，当前的植入式心脏扭曲器除颤器（ICDS）的当前指南建议延迟植入（> 40天）。延迟植入留下了一个未受保护的窗口，即ICD植入之前，猝死风险增加。此外，仅使用左心室射血分数（EF）来确定MI后患者是否应随后获得ICD，以预防猝死。在这种情况下，只有20％的患者会在未来5年内具有自发性心律不齐。需要一种更具成本效益的方法，用于选择初级预防ICD植入患者。为了解决这两种缺陷，我们建议预防早期猝死试验（背心）的背心和ICD疗法研究的预测（预测）。该提案寻求用于临床协调中心的资金，链接的R01（PI Hulley）用于数据协调中心，其余资金（80％）将来自行业。背心是一项多中心，随机，对照的试验，可确定在ML左心室功能障碍患者ML后，非侵入性可穿戴除颤器背心是否会降低总体死亡率（EF <35％）。预测是这种随机干预措施的后续措施，其中，背心的参与者将经过一系列风险分层测试，包括T波替代品，BaroreFlex灵敏度，Holter Monumiting和7其他可能的预测指标，然后再放置ICD。然后，将在未来5年内监视参与者的ICD冲击和其他临床结果。这些数据将用于开发和验证多变量的风险分层工具，该工具可以预测发生“令人震惊的”心室心律不齐的发生，并有效地识别出I​​CD最具成本效益的高危患者（并且低风险患者不需要ICD的低风险患者）。两项研究的生物样本和数据将被存储并提供给外部研究人员以供将来的研究。我们预计，背心和预测将对美国的500,000次年度突然死亡产生重大影响，该干预措施可以保护最高风险的早期MI早期患者，并通过确定风险分层策略来识别风险最高和最低风险的风险分层策略，并使ICD植入更具成本效益。

项目成果

Wearable Cardioverter-Defibrillator after Myocardial Infarction.

• DOI: 10.1056/nejmoa1800781
• 发表时间: 2018-09-27
• 期刊: The New England journal of medicine
• 作者: Olgin JE;Pletcher MJ;Vittinghoff E;Wranicz J;Malik R;Morin DP;Zweibel S;Buxton AE;Elayi CS;Chung EH;Rashba E;Borggrefe M;Hue TF;Maguire C;Lin F;Simon JA;Hulley S;Lee BK;VEST Investigators
• 通讯作者: VEST Investigators

Impact of wearable cardioverter-defibrillator compliance on outcomes in the VEST trial: As-treated and per-protocol analyses.

• DOI: 10.1111/jce.14404
• 发表时间: 2020-05
• 期刊: JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY
• 影响因子: 2.7
• 作者: Olgin, Jeffrey E.;Lee, Byron K.;Vittinghoff, Eric;Morin, Daniel P.;Zweibel, Steven;Rashba, Eric;Chung, Eugene H.;Borggrefe, Martin;Hulley, Stephen;Lin, Feng;Hue, Trisha F.;Pletcher, Mark J.
• 通讯作者: Pletcher, Mark J.

Predicting Persistent Left Ventricular Dysfunction Following Myocardial Infarction: The PREDICTS Study.

• DOI: 10.1016/j.jacc.2015.12.042
• 发表时间: 2016-03-15
• 期刊: Journal of the American College of Cardiology
• 影响因子: 24
• 作者: Brooks GC;Lee BK;Rao R;Lin F;Morin DP;Zweibel SL;Buxton AE;Pletcher MJ;Vittinghoff E;Olgin JE;PREDICTS Investigators
• 通讯作者: PREDICTS Investigators