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

University of Leipzig

Status and phase: Unknown; Phase 3; Phase 2

Conditions: CAD; Stable Angina Pectoris

Treatments: Behavioral: Exercise Training; Device: PTCA and Stent Implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00176358

139/2001

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)