Reducing Vulnerability to ICD Shock Treated Ventricular Arrhythmias

减少 ICD 电击治疗室性心律失常的脆弱性

• 批准号: 7681536
• 负责人: Matthew M Burg
• 金额: $ 39.12万
• 依托单位: YALE UNIVERSITY
• 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 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7681536
• 关键词: Acute; Adverse effects; Anger; Anti-Arrhythmia Agents; Anxiety; Arrhythmia; Behavioral; Cardiomyopathies; Caring; Cessation of life; Clinical Trials; Cognitive; Devices; Disease-Free Survival; Emotional Stress; Emotions; Event; Frequencies; Heart Arrest; Hospitalization; Hospitals; Hour; Implantable Defibrillators; Intervention; Ischemia; Laboratories; Left Ventricular Function; Life; Malignant - descriptor; Measures; Medicaid; Morphology; Patient Care; Patients; Pharmaceutical Preparations; Prevalence; Protocols documentation; Psyche structure; Quality of life; Randomized; Randomized Clinical Trials; Recording of previous events; Recruitment Activity; Relative Risks; Research Personnel; Risk; Secondary Prevention; Severities; Shock; Stress; Testing; Therapeutic; Time; Ventricular Arrhythmia; Work; acute coronary syndrome; acute stress; base; depression; experience; heart rate variability; implantation; improved; programs; psychologic; response; treatment as usual

DESCRIPTION (provided by applicant): Upwards of 400,000 people in the US experience cardiac arrest annually, and the implantable cardioverter- defibrillator (ICD) has transformed the care of patients at risk for these potentially fatal arrhythmias. The results of recent clinical trials have led to an expansion of the indications for ICD therapy, and it is estimated that over 500,000 patients will receive these devices annually. While ICDs can be life saving, significant adjustment problems and impaired quality of life (QOL) can arise as a function of ICD shock frequency. Further, adjustment problems increase the likelihood of arrhythmias requiring shock for termination. Working in the laboratory and in the natural setting, we have identified the experience and response to acute emotional stress as specific vulnerabilities to the occurrence of arrhythmias that require shock for termination. We have therefore identified a potential target for intervention - mental/emotional stress - to reduce vulnerability to arrhythmia requiring shock in patients with ICD. Stress reduction treatments have been shown to reduce vulnerability to emotion-triggered ischemia, and improve event free survival after ACS. Therefore, the Specific Aims of the proposed study are to test, in a randomized clinical trial with new ICD patients, the effects of a stress reduction intervention (SRT) on, 1) shock-treated arrhythmia, 2) arrhythmogenic electrophysiological (EP) changes during acute stress in the laboratory, and, 3) Quality of Life. A total of 304 patients will recruited while in hospital at the time of ICD receipt and be randomized to usual care or a 12-week, group based, cognitive behavioral stress reduction treatment (SRT). Primary endpoints include shock treated arrhythmia event-free survival over 2 years, pro-arrhythmic EP changes during laboratory mental stress, 24-hour heart rate variability, and quality of life. Secondary endpoints include anti-arrhythmic medication changes, hospitalizations, deaths, and psychological measures of anger. RELEVANCE: Confirmation of hypotheses concerning the benefits of SRT treatment could transform the care of ICD patients. Patients receiving these devices could be offered SRT prophylactically to reduce the risk of arrhythmia requiring shock for termination. In addition, should the effect of SRT be particularly greater for those patients prone to anger, ICD patients at risk due to anger could be identified prospectively, and SRT particularly targeted to them.

描述（由申请人提供）：美国每年有超过40万人经历心脏骤停，植入式心律转复除颤器（ICD）改变了对这些潜在致命性心律失常风险患者的护理。最近的临床试验结果导致ICD治疗的适应症扩大，估计每年将有超过50万患者接受这些设备。虽然ICD可以挽救生命，但作为ICD电击频率的函数，可能会出现严重的调整问题和生活质量（QOL）受损。此外，调节问题增加了需要电击终止的心律失常的可能性。在实验室和自然环境中工作，我们已经确定了对急性情绪压力的体验和反应是发生需要电击终止的心律失常的特定脆弱性。因此，我们确定了一个潜在的干预目标-精神/情绪压力-以减少ICD患者发生需要电击的心律失常的可能性。减压治疗已被证明可以减少对情绪触发的缺血的脆弱性，并提高ACS后的无事件生存率。因此，拟定研究的具体目的是在新ICD患者的随机临床试验中测试减压干预（SRT）对以下方面的影响：1）休克治疗的心律失常，2）实验室急性应激期间的致心律失常性电生理（EP）变化，3）生活质量。总共招募了304名患者，他们在接受ICD时住院，并被随机分配到常规护理或12周的基于小组的认知行为减压治疗（SRT）。主要终点包括2年内接受电击治疗的心律失常无事件生存率、实验室精神应激期间的促心律失常EP变化、24小时心率变异性和生活质量。次要终点包括抗抑郁药物的变化，住院，死亡和愤怒的心理测量。相关性：证实关于SRT治疗益处的假设可能会改变ICD患者的护理。接受这些器械的患者可主动接受SRT，以降低需要电击终止的心律失常风险。此外，如果SRT的效果对于那些容易愤怒的患者特别大，则可以前瞻性地识别由于愤怒而处于风险中的ICD患者，并且SRT特别针对他们。