Status:
UNKNOWN
Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease
Lead Sponsor:
University of Leipzig
Conditions:
CAD
Stable Angina Pectoris
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
- \< 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00176358
Last Update
September 10 2007
Active Locations (1)
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1
University of Leipzig - Heart Center
Leipzig, Germany, 04289