COMPARISON OF ELECTROPHYSIOLOGIC STUDY TO ECG MONITORING

电生理学研究与心电图监测的比较

• 批准号: 3346649
• 负责人: Jay W. Mason
• 金额: $ 90.4万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-07-01 至 1992-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3346649
• 关键词: antiarrhythmic agent; cardiovascular stress test; clinical trials; disease /disorder classification; drug adverse effect; electrophysiology; heart disorder chemotherapy; heart disorder diagnosis; human subject; human therapy evaluation; premature ventricular contractions; sudden cardiac death; tachycardia; ventricular fibrillation

Electrophysiologic Study vs. Electrocardiographic Monitoring (ESVEM) is a multicenter, investigator-initiated, clinical trial which began enrollment on 10/1/85. The investigators hypothesize that either electrophysiologic study (EPS) or Holter monitoring (HM) is more accurate in identifying antiarrhythmic drug efficacy in patients with ventricular tachyarrhythmias (VTA). Subjects with inducible (VTA) and greater than or equal to 10 ventricular ectopic beats per hour are randomized at 12 enrolling centers to undergo serial drug efficacy testing by one or the other method. They may receive up to six antiarrhythmics in random order until one is predicted to be effective by suppression of inducible VTA in the EPS limb or suppression of ectopy in the HM limb. Estimation of the median time to arrhythmia recurrence in subjects with an efficacy prediction is the primary analysis by which we will compare the two testing methods. On 2/15/90, 407 subjects had been randomized and a drug efficacy prediction had been achieved in 236. The goal is to enter 290 patients into long-term follow-up on drugs predicted effective by one of the testing methods. This goal should be reached by 5/31/91, and the trial will conclude one year later. A three year period of funding is needed for completion of the trial, data analysis and reporting. Twelve additional objectives include: A study of the concordance between HM and EPS; a comparison of the relative cost and the cost-effectiveness of the two approaches; an evaluation of the role of HM in monitoring long-term drug efficacy; an examination of heart period variability as a predictor of malignant arrhythmias; delineation of the influence of left ventricular dysfunction upon antiarrhythmic drug efficacy; and use of body surface potential mapping to identify arrhythmia vulnerability. Considerable controversy persists over whether patients with VTA should receive antiarrhythmic therapy based upon EPS or HM. This study will help clarify most issues in that controversy. It will provide new information concerning risk assessment in patients with VTA which may help define the subgroups at greatest risk, as well as those more likely to benefit from therapy. This project will develop refinements in the application of EPS and HM and in the interpretation of their results.

电生理学研究与心电图监测（ESVEM）是一种 开始入组的多中心、制药商发起的临床试验 10/1/85研究人员假设， 研究（EPS）或霍尔特监测（HM）在识别 室性快速性心律失常患者的抗心律失常药物疗效 （VTA）。诱导型（VTA）和≥ 10的受试者 每小时心室异位搏动在12个招募中心随机分配 通过一种或另一种方法进行系列药效试验。他们 可以随机顺序接收多达六个抗干扰素，直到其中一个被 通过抑制EPS肢体中的诱导性VTA预测有效 或抑制HM肢体的异位。中位时间估计 具有疗效预测的受试者心律失常复发率是 主要分析，我们将比较两种测试方法。对 2090年2月15日，407例受试者接受了随机化，并进行了药物疗效预测 已于236年实现。目标是让290名患者进入长期治疗 对其中一种测试方法预测有效的药物进行随访。这 目标应于1991年5月31日达到，试验将结束一年 后需要三年的资金来完成 试验、数据分析和报告。 12个额外的目标包括： HM和EPS;相对成本和成本效益的比较 两种方法中的一种;对HM在监测 长期药物疗效;检查心脏周期变异性作为一种 恶性心律失常的预测因子;左室舒张功能的影响 抗心律失常药物疗效后的心室功能障碍;以及 表面电位标测以识别心律失常脆弱性。 关于腹侧被盖区患者是否应该 接受基于EPS或HM的抗抑郁治疗。这项研究将帮助 澄清了这场争论中的大部分问题。它将提供新的信息 关于VTA患者的风险评估，这可能有助于确定 风险最大的亚组，以及那些更有可能受益于 疗法本项目将改进EPS的应用 和HM以及对结果的解释。