A Clinical Coordinating Center for VEST and PREDICTS

VEST 和 PREDICTS 临床协调中心

• 批准号: 7493416
• 负责人: Jeffrey E Olgin
• 金额: $ 75.82万
• 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/7493416
• 关键词: Address; Applications Grants; Arrhythmia; Baroreflex; Biological; Caring; Cause of Death; Clinical; Cohort Studies; Collection; Commit; Convulsive therapy; DNA; Data; Data Collection; Data Coordinating Center; Death Rate; Defibrillators; Depressed mood; EFRAC; Echocardiography; End Point; Enrollment; Ensure; Equipment; Event; Funding; Future; Guidelines; Holter Electrocardiography; Hospitals; Implant; Implantable Defibrillators; Individual; Industry; Institution; Intervention; Invasive; Investigation; Left; Left Ventricular Dysfunction; Left Ventricular Ejection Fraction; Left Ventricular Function; Link; Measurement; Medical; Methods; Monitor; Multicenter Studies; Multicenter Trials; Myocardial Infarction; Nature; Outcome; Participant; Patients; Placement; Policies; Prevention; Primary Prevention; Procedures; Protocols documentation; Public Health; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Rate; Research Personnel; Resources; Risk; Sampling; Serum Proteins; Shock; Standards of Weights and Measures; Stratification; Sudden Death; Tachycardia; Testing; Time; United States National Institutes of Health; Ventricular Arrhythmia; adjudication; base; clinical research site; cohort; cost; day; design; follow-up; implantation; mortality; prevent; programs; prospective; repository; sudden cardiac death; 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）：尽管心肌梗死（MI）后前2个月内猝死的发生率很高，但植入式心律转复除颤器（ICD）的现行指南建议低射血分数（EF）患者在MI后延迟植入（>40天）。延迟植入会在植入ICD之前留下一个未受保护的猝死风险增加窗口。此外，仅使用左心室射血分数（EF）来决定MI后患者随后是否应接受ICD以进行猝死的一级预防。在这种情况下，只有20%的患者将在未来5年内发生需要ICD电击的自发性室性心律失常。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，我们提出了早期猝死的背心预防试验（VEST）和ICd治疗的预测研究（PREDICTS）。该提案旨在为临床协调中心提供资金，相关的R01（PI Hulley）用于数据协调中心，其余资金（80%）将来自行业。VEST是一项多中心、随机、对照试验，旨在确定无创可穿戴除颤器背心是否会降低左心室功能不全（EF<35%）患者MI后前60天内的总体死亡率。PREDICTS是该随机干预的后续研究，其中VEST的参与者将在植入ICD前接受一系列风险分层测试，包括T波交替、压力反射敏感性、霍尔特监测和其他7个可能的预测因素。然后将在未来5年内监测参与者的ICD电击和其他临床结局。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“可电击”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）。将储存两项研究的生物样本和数据，并提供给外部研究者用于未来研究。我们预计，VEST和PREDICTS将通过测试可能保护极高风险的早期MI后患者的干预措施，并通过确定风险分层策略来识别最高和最低风险的患者，并使ICD植入更具成本效益，从而对美国每年50万例猝死产生重大影响。