Internal Medicine-Cardiologym Yale University School of Medicine, New Haven, CT, USA.
Psychosom Med. 2010 Feb;72(2):172-7. doi: 10.1097/PSY.0b013e3181c932d4. Epub 2009 Dec 22.
To present the design of a multicenter, randomized trial testing the effects of stress reduction treatment (SRT) on the prevalence of shock-treated ventricular arrhythmias among patients with an implantable cardioverter defibrillator (ICD). Significant adjustment problems secondary to ICD shock can increase the likelihood of arrhythmias requiring shock for termination. Whether SRT can reduce arrhythmias requiring shock for termination in patients with ICDs has not been tested in clinical trials.
New ICD recipients and previous recipients who have received an appropriate therapeutic shock in the last 6 months (n = 304) will be enrolled and randomized to either SRT or usual cardiac care. Participants complete a psychosocial questionnaire and undergo laboratory mental stress testing and 24-hour Holter monitoring with diary at study entry and approximately 4 months later. Follow-ups are completed at 6, 12, and 24 months post randomization to assess occurrence of ICD shock for ventricular arrhythmias (primary outcome), antitachycardia pacing events, medication changes, hospitalizations, deaths, and quality of life.
Log-rank test and Cox proportional hazards model will be used to test the effects of SRT on time to first shock-treated ventricular arrhythmia, with exploratory analyses testing the effects on overall frequency of ventricular arrhythmia. Secondary analyses will test the effects of SRT on laboratory stress-induced and 24-hour arrhythmogenic electrophysiological indices from pre to post treatment, and both quality of life and measures of anger across the 2 years of the study.
The Reducing Vulnerability to ICD Shock-Treated Ventricular Arrhythmias (RISTA) Trial is the first large-scale, randomized, clinical trial designed to evaluate the effect of SRT on the prevalence of shock-treated arrhythmias among patients with an ICD. Results may demonstrate a treatment that can reduce vulnerability to arrhythmia-provoked shock and improve quality of life.
介绍一项多中心、随机试验的设计，该试验旨在测试减压治疗（SRT）对植入式心脏复律除颤器（ICD）患者电击治疗室性心律失常发生率的影响。由于 ICD 电击，可能会出现显著的调整问题，从而增加心律失常需要电击终止的可能性。SRT 是否可以降低 ICD 患者心律失常需要电击终止的风险，尚未在临床试验中得到验证。
将招募并随机分配新的 ICD 接受者和过去 6 个月内接受过适当治疗性电击的 ICD 接受者（n = 304）至 SRT 组或常规心脏护理组。参与者完成心理社会问卷，并在研究开始时和大约 4 个月后进行实验室心理应激测试和 24 小时动态心电图监测及日记记录。在随机分组后 6、12 和 24 个月进行随访，以评估 ICD 电击治疗室性心律失常（主要结局）、抗心动过速起搏事件、药物变化、住院、死亡和生活质量的发生情况。
对数秩检验和 Cox 比例风险模型将用于测试 SRT 对首次电击治疗室性心律失常时间的影响，探索性分析测试 SRT 对总体室性心律失常频率的影响。次要分析将测试 SRT 对治疗前后实验室应激诱导和 24 小时心律失常电生理指标的影响，以及研究的 2 年内生活质量和愤怒的测量。
降低 ICD 电击治疗室性心律失常易感性（RISTA）试验是第一项旨在评估 SRT 对 ICD 患者电击治疗心律失常发生率影响的大型、随机临床试验。研究结果可能表明存在一种治疗方法，可以降低心律失常引起电击的易感性并改善生活质量。
