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: 3346654
• 负责人: Jay W. Mason
• 金额: $ 74.05万
• 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 1993-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3346654
• 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.

电生理研究与心电监测(ESVEM)是一种 由研究人员发起的多中心临床试验已开始登记 在85年10月1日。研究人员假设，要么是电生理学 检查(EPS)或动态心电监测(HM)更能准确识别 室性快速性心律失常患者的抗心律失常药物疗效 (VTA)。具有诱导性(VTA)且大于或等于10的受试者 每小时室性异位搏动在12个登记中心随机进行 通过一种或另一种方法进行系列药效试验。他们 可以以随机顺序接受最多六种抗心律失常药物，直到其中一种 预测通过抑制EPS肢体中的诱导性VTA而有效 或抑制HM肢体的异位。中位数时间的估计 有疗效预测的受试者心律失常复发是 初步分析，我们将通过这两种测试方法进行比较。在……上面 2/15/90,407名受试者被随机分组并进行药物疗效预测 已在236年实现。目标是让290名患者进入长期 对其中一种检测方法预测有效的药物进行随访。这 目标应在1991年5月31日前达到，试验将结束一年 后来。需要三年的资助期才能完成 试验、数据分析和报告。 其他12个目标包括：研究两国之间的一致性 HM与EPS；相对成本与成本效益的比较 两种方法中的一种；对卫生管理在监测中的作用的评价 长期药物疗效；心脏周期变异性检查作为一种 恶性心律失常的预测指标；左心功能的影响 心功能障碍对抗心律失常药物疗效的影响；以及身体的使用 体表电位标测以识别心律失常易损性。 关于室上性心动过速患者是否应该 接受基于EPS或HM的抗心律失常治疗。这项研究将会有所帮助 澄清这场争议中的大多数问题。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 风险最大的亚群，以及更有可能受益于 心理治疗。该项目将进一步完善EPS的应用 和HM以及对他们结果的解释。

项目成果

The ESVEM trial. Electrophysiologic Study Versus Electrocardiographic Monitoring for selection of antiarrhythmic therapy of ventricular tachyarrhythmias. The ESVEM Investigators.

ESVEM 试验。

• DOI: 10.1161/01.cir.79.6.1354
• 发表时间: 1989
• 期刊: Circulation
• 影响因子: 37.8

Cost of initial therapy in the Electrophysiological Study Versus ECG Monitoring trial (ESVEM).

电生理学研究与心电图监测试验 (ESVEM) 初始治疗的费用。

• DOI: 10.1161/01.cir.91.4.1070
• 发表时间: 1995
• 期刊: Circulation
• 影响因子: 37.8
• 作者: Omoigui,NA;Marcus,FI;Mason,JW;Hahn,EA;Hartz,VL;Hlatky,MA
• 通讯作者: Hlatky,MA

Design and analysis of the ESVEM Trial.

ESVEM 试验的设计和分析。

• DOI: 10.1016/s0033-0620(96)80012-0
• 发表时间: 1996
• 期刊: Progress in cardiovascular diseases
• 影响因子: 9.1
• 作者: Anderson,KP;Hartz,VL;Hahn,EA;Moon,TE
• 通讯作者: Moon,TE

Long-term cost-effectiveness of alternative management strategies for patients with life-threatening ventricular arrhythmias. Electrophysiologic Study versus Electrocardiographic Monitoring (ESVEM) Investigators.

对于危及生命的室性心律失常患者的替代管理策略的长期成本效益。

• DOI: 10.1016/s0895-4356(96)00331-9
• 发表时间: 1997
• 期刊: Journal of clinical epidemiology
• 影响因子: 7.2
• 作者: Hlatky,MA;Boothroyd,DB;Johnstone,IM;Marcus,FI;Hahn,E;Hartz,V;Mason,JW
• 通讯作者: Mason,JW

Clinical significance of syncope in the electrophysiologic study versus electrocardiographic monitoring (ESVEM) trial. The ESVEM Investigators.

电生理学研究与心电图监测 (ESVEM) 试验中晕厥的临床意义。

• DOI: 10.1016/s0002-8703(99)70412-6
• 发表时间: 1999
• 期刊: American heart journal
• 影响因子: 4.8
• 作者: Olshansky,B;Hahn,EA;Hartz,VL;Prater,SP;Mason,JW
• 通讯作者: Mason,JW