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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of Leipzig.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00176358
First received: September 9, 2005
Last updated: September 7, 2007
Last verified: September 2005

September 9, 2005
September 7, 2007
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Complete list of historical versions of study NCT00176358 on ClinicalTrials.gov Archive Site
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Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease
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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).

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Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • CAD
  • Stable Angina Pectoris
  • Device: PTCA and Stent Implantation
  • Behavioral: Exercise Training
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
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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
Both
18 Years to 75 Years
No
Contact: Rainer Hambrecht, Prof. 00493418651426 rhambrecht@medizin.uni-leipzig.de
Germany
 
NCT00176358
139/2001
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University of Leipzig
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Principal Investigator: Rainer Hambrecht, Prof. University of Leipzig
University of Leipzig
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP