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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00176358
Recruitment Status : Unknown
Verified September 2005 by University of Leipzig.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : September 10, 2007
Information provided by:
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).

Condition or disease Intervention/treatment Phase
CAD Stable Angina Pectoris Device: PTCA and Stent Implantation Behavioral: Exercise Training Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00176358

Contact: Rainer Hambrecht, Prof. 00493418651426

University of Leipzig - Heart Center Recruiting
Leipzig, Germany, 04289
Contact: Sven Möbius-Winkler, MD    00493418650      
Sub-Investigator: Sven Möbius-Winkler, MD         
Sub-Investigator: Claudia Walther, MD         
Sponsors and Collaborators
University of Leipzig
Principal Investigator: Rainer Hambrecht, Prof. Heart Center Leipzig - University Hospital Identifier: NCT00176358     History of Changes
Other Study ID Numbers: 139/2001
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 10, 2007
Last Verified: September 2005

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms