TRIGGERS OF VENTRICULAR ARRHYTHMIAS (TOVA) STUDY

室性心律失常 (TOVA) 触发因素研究

• 批准号: 6389071
• 负责人: JAMES E MULLER
• 金额: $ 52.08万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1990
• 资助国家: 美国
• 起止时间: 1990-04-01 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6389071
• 关键词: amiodarone; angers; beta antiadrenergic agent; cardiovascular disorder epidemiology; cardiovascular disorder prevention; chemoprevention; circadian rhythms; clinical research; disease /disorder proneness /risk; exercise; human subject; implantable defibrillators; longitudinal human study; seasons; sex behavior; sudden cardiac death; ventricular fibrillation

This is an application for competitive renewal of our prior NHLBI grant that characterized triggering of non-fatal myocardial infarction (MI). We propose to apply the methods and findings of our MI study to characterize triggering of discharge of implantable cardioverter-defibrillators (ICDs). The long-term objective of the Triggers of Ventricular Arrhythmias (TOVA) Study is to gain insights into triggering useful for prevention of sudden cardiac death (SCD) due to primary arrhythmia in the general population; as a secondary objective we will obtain information useful for prevention of ICD discharge. Available evidence, largely anecdotal, indicates that activities associated with activation of the sympathetic nervous system trigger both SCD and ICD discharge. We will study patients with ICDs because 1) SCD victims cannot give historical triggering data, 2) ICD patients, who have a high rate of events, can be studied prospectively, and 3) electrograms from ICDs are a novel source for information about rate and rhythm prior to ICD discharge. TOVA study will utilize a cohort design with a nested case-crossover analysis, which permitted identification of triggering in over 17 percent of non-fatal MIs in our prior study. A pilot study of 164 patients with ICDs has demonstrated possible triggering in 23 percent of 39 discharges. We will characterize triggering in 2,000 episodes of ICD discharge in 3,000 patients treated in 44 centers nationwide over 4 years. Partial funding has been pledged by industry. The specific aims of this study are: 1) To identify activities, such as heavy exertion, that trigger ICD discharge; 2) To determine factors, such as beta-blockade, that modify the susceptibility to triggering; 3) To determine if ICD discharges occur more frequently in the 3 hours after awakening, on Monday, and in winter; and, 4) To utilize electrograms recorded prior to ICD discharge to identify sympathetic activation during triggering. Characterization of triggering of ICD discharge will provide insights valuable for prevention of sudden death due to primary arrhythmias in the general population.

这是我们之前 NHLBI 拨款的竞争性更新申请，其特征是触发非致命性心肌梗死 (MI)。 我们建议应用 MI 研究的方法和结果来表征植入式心律转复除颤器 (ICD) 的放电触发。室性心律失常触发因素 (TOVA) 研究的长期目标是深入了解触发因素，有助于预防一般人群中原发性心律失常引起的心源性猝死 (SCD)；作为次要目标，我们将获得有助于预防 ICD 放电的信息。现有证据（主要是轶事）表明，与交感神经系统激活相关的活动会触发 SCD 和 ICD 放电。 我们将研究 ICD 患者，因为 1) SCD 受害者无法提供历史触发数据，2) 事件发生率较高的 ICD 患者可以进行前瞻性研究，3) ICD 电图是有关 ICD 出院前心率和心律信息的新来源。 TOVA 研究将采用带有嵌套病例交叉分析的队列设计，在我们之前的研究中，该设计允许识别超过 17% 的非致命性心梗的触发因素。 对 164 名佩戴 ICD 的患者进行的一项试点研究表明，39 例出院患者中有 23% 可能会触发。 我们将描述 4 年来在全国 44 个中心治疗的 3,000 名患者中 2,000 次 ICD 放电的触发情况。工业界已承诺提供部分资金。本研究的具体目的是： 1) 确定触发 ICD 放电的活动，例如重体力劳动； 2) 确定改变触发敏感性的因素，例如β-阻断； 3) 确定ICD放电是否在醒来后3小时、周一和冬季更频繁发生； 4) 利用 ICD 放电之前记录的电图来识别触发期间的交感神经激活。 ICD 放电触发的表征将为预防普通人群因原发性心律失常引起的猝死提供有价值的见解。