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

Stable Angina Pectoris Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00176358
• Other study ID #: 139/2001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: September 7, 2007

Study information

• Verified date: September 2005
• Source: University of Leipzig
• Contact: Rainer Hambrecht, Prof.
• Phone: 00493418651426
• Email: rhambrecht[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• CAD
• Stable Angina Pectoris

Intervention

Device:
• PTCA and Stent Implantation

Behavioral:
• Exercise Training

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany,