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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University of Leipzig.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176358
First Posted: September 15, 2005
Last Update Posted: September 10, 2007
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.
Information provided by:
University of Leipzig
  Purpose
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 Intervention Phase
CAD Stable Angina Pectoris Device: PTCA and Stent Implantation Behavioral: Exercise Training Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Leipzig:

Estimated Enrollment: 400
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00176358


Contacts
Contact: Rainer Hambrecht, Prof. 00493418651426 rhambrecht@medizin.uni-leipzig.de

Locations
Germany
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
Investigators
Principal Investigator: Rainer Hambrecht, Prof. Heartcenter Leipzig GmbH
  More Information

ClinicalTrials.gov Identifier: NCT00176358     History of Changes
Other Study ID Numbers: 139/2001
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: September 10, 2007
Last Verified: September 2005

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