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

This study is currently recruiting participants.

Verified by University of Leipzig, September 2005

Sponsored by:	University of Leipzig
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00176358

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 II Phase III

MedlinePlus related topics: Angina Angioplasty Coronary Artery Disease Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

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

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Pain
Arteriosclerosis
Ischemia
Coronary Artery Disease
Chest Pain

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009