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

NCT ID: NCT00176358

Last Updated: 2007-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

CAD Stable Angina Pectoris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PTCA and Stent Implantation

Intervention Type DEVICE

Exercise Training

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Leipzig

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rainer Hambrecht, Prof.

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Leipzig - Heart Center

Leipzig, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rainer Hambrecht, Prof.

Role: CONTACT

00493418651426

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sven Möbius-Winkler, MD

Role: primary

00493418650

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

139/2001

Identifier Type: -

Identifier Source: org_study_id