MedPath

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

Phase 2
Conditions
CAD
Stable Angina Pectoris
Registration Number
NCT00176358
Lead Sponsor
University of Leipzig
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
400
Inclusion Criteria
  • 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 Criteria
  • < 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Leipzig - Heart Center

🇩🇪

Leipzig, Germany

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