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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
History of Changes
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Estimated Enrollment: 400
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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. University of Leipzig
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00176358     History of Changes
Other Study ID Numbers: 139/2001
Study First Received: September 9, 2005
Last Updated: September 7, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 16, 2013