Data Coordinating Center for VEST and PREDICTS

描述（由申请人提供）：尽管在心肌梗死（Ml）后的头2个月内猝死率很高，但目前的植入式心律转复除颤器（ICDs）指南建议低射血分数（EF）患者在Ml后延迟植入（>40天）。延迟植入给ICD植入前的猝死风险增加留下了一个无保护的窗口期。此外，仅使用左室射血分数（EF）来决定心肌梗死后患者是否应随后接受ICD以预防猝死。在这种情况下，只有20%的患者在未来5年内会发生自发性室性心律失常，需要ICD电击。需要一种更具成本效益的方法来选择患者进行一级预防ICD植入。为了解决这两个缺陷，我们提出了Vest预防早期猝死试验（Vest）和ICd治疗预测研究（predict）。该提案为临床协调中心寻求资金，关联的R01 （PI Hulley）为数据协调中心，其余的资金（80%）将来自工业界。VEST是一项多中心、随机、对照试验，旨在确定非侵入性穿戴式除颤器背心是否会降低左心室功能障碍（EF<35%）患者Ml后60天内的总死亡率。predict是该随机干预的后续研究，VEST的参与者将在放置ICD之前接受一系列风险分层测试，包括T波交替、气压反射敏感性、动态心电图监测和其他7种可能的预测指标。在接下来的5年里，参与者将被监测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风险分层工具，该工具可预测“震荡性”室性心律失常的发生，并有效识别ICD最具成本效益的高风险患者（以及不需要ICD的低风险患者）。这两项研究的生物样本和数据将被储存起来，供外部调查人员用于未来的研究。我们预计，VEST和predict将对美国每年50万的猝死人数产生重大影响，通过测试一种干预措施，可能会保护高危早期心肌梗死后患者，并通过确定风险分层策略，识别高风险和低风险患者，使ICD植入更具成本效益。

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.