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

Primary Purpose

CAD, Stable Angina Pectoris

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
PTCA and Stent Implantation
Exercise Training
Sponsored by
University of Leipzig
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for CAD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Leipzig - Heart CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
September 7, 2007
Sponsor
University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT00176358
Brief Title
Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Leipzig

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CAD, Stable Angina Pectoris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PTCA and Stent Implantation
Intervention Type
Behavioral
Intervention Name(s)
Exercise Training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Hambrecht, Prof.
Phone
00493418651426
Email
rhambrecht@medizin.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Hambrecht, Prof.
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, MD
Phone
00493418650
First Name & Middle Initial & Last Name & Degree
Sven Möbius-Winkler, MD
First Name & Middle Initial & Last Name & Degree
Claudia Walther, MD

12. IPD Sharing Statement

Learn more about this trial

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

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