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临床试验/NCT01174797
NCT01174797已完成不适用

Evaluation of Microvolt T-Wave Alternans Testing for the Detection of Active Ischemia in Patients With Known or Suspected Coronary Artery Disease: A Feasibility Study

Cambridge Heart Inc.2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
186
试验地点
2

研究概览

简要总结

MTWA-CAD is a feasibility study designed to evaluate Microvolt T-Wave Alternans (MTWA) testing for the purpose of detecting active ischemia in patients with known or suspected coronary artery disease (CAD). MTWA is a subtle, alternating pattern in the T wave portion of the surface electrocardiogram (ECG) that is associated with increased risk of ventricular tachyarrhythmias and sudden cardiac arrest (SCA).

详细描述

Ischemia, a common trigger for arrhythmias, is a well-documented cause of repolarization alternans. Human studies have shown that active ischemia can be associated with visible as well as microvolt-level T-wave alternans. While MTWA testing is traditionally used to evaluate arrhythmic risk, this known association with ischemia may allow MTWA testing to be used as a diagnostic tool to detect underlying CAD. The MTWA-CAD study will assess the feasibility of this concept by measuring MTWA during routine nuclear stress testing or stress echocardiography with treadmill exercise. This is a feasibility study designed to verify preliminary observations under controlled environments and to generate hypotheses, endpoints, and sample sizes for future investigations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or above, or of legal age to give informed consent specific to state and national law
  • Willing and capable of providing informed consent
  • Willing and capable of undergoing a SPECT MPI exercise test (or stress echo) at an approved clinical investigational center
  • In normal sinus rhythm at the time of the exercise test
  • A life expectancy of more than 6 months

排除标准

  • In atrial fibrillation at the time of the exercise test
  • Left bundle branch block (precludes ST segment measurement)
  • Pacemaker-dependent
  • Life expectancy of less than 6 months
  • Pregnancy

研究者

发起方
Cambridge Heart Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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