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临床试验/NCT00176358
NCT00176358Unknown2 期

Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease

University of Leipzig2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2005年9月15日最近更新:
适应症

试验速览

阶段
2 期
发起方
入组人数
400
试验地点
2

研究概览

简要总结

The purpose of this study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (CAD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Angiographically documented CAD, with at least one coronary artery stenosis of more than 50% in a native segment never subjected to intervention, which is recommended for treatment with percutaneous transluminal coronary angioplasty (PTCA).
  • Stable coronary artery disease
  • Eligible patients could be asymptomatic or have class I to III angina (Canadian Cardiovascular Society [CCS]) with documented myocardial ischemia
  • Angina pectoris threshold > 50 Watt (cycle ergometry)
  • Permanent residence should be within 25 km of training facility.

排除标准

  • < 18 or > 70 years of age
  • Patient currently participating in an exercise training program
  • Unstable angina pectoris or myocardial infarction during the last 2 weeks
  • Symptoms of CCS class IV
  • Exercise limitations due to clinical conditions not related to CAD
  • Left ventricular ejection fraction (LVEF) of < 40%
  • Ventricular arrhythmia (Lown Ivb)
  • Hemodynamically significant valvular heart disease
  • Previous cardiac surgery
  • PTCA performed during the last 12 months
  • Any major non-cardiac condition that would adversely affect survival during the duration of the study
  • Reduced compliance

研究者

发起方
University of Leipzig
申办方类型
Other

研究点 (2)

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