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Impact of Exercise Training on Endothelial Function in CAD

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Exercise Training

About this trial

This is an interventional educational/counseling/training trial for Coronary Artery Disease focused on measuring exercise training, endothelial function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: stable CAD male gender Exclusion Criteria: insulin-dependent diabetes mellitus significant valvular heart disease smoking exercise-induced myocardial ischemia conditions prohibiting exercise training

Sites / Locations

University of Leipzig, Heart Center, Department of Internal Medicine / CardiologyRecruiting

Outcomes

Primary Outcome Measures

Endothelial function

Secondary Outcome Measures

Full Information

NCT ID

NCT00176345

First Posted

September 11, 2005

Last Updated

September 11, 2005

Sponsor

University of Leipzig

1. Study Identification

Unique Protocol Identification Number

NCT00176345

Brief Title

Impact of Exercise Training on Endothelial Function in CAD

Official Title

Impact of Exercise Training on Bradykinin-Mediated Endothelial Function in Patients With Coronary Artery Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

January 2001 (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

Bradykinin has been identified to contribute to the release of nitric oxide (NO), prostacyclin, and EDHF through activation of specific bradykinin 2 (B2) receptors, which is finally promoting a vasodilatory respone. Regular physical exercise training results in an improvement of endothelial function in patients with CAD. These positive effects were partially attributed to an increased expression of endothelial NO synthase (eNOS) and cyclooxygenase (COX) as a result of the training intervention. Aim of this trial is therefore to determine, whether the training-induced correction of endothelial dysfunction is also bradykinin-dependent.

Detailed Description

A total of 20 patients with stable coronary artery disease are prospectively randomized to 4 weeks of exercise training or sedentary lifestyle. Endothelial function of the radial artery is determined by a high-resolution A-mode ultrasound.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

exercise training, endothelial function

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Exercise Training

Primary Outcome Measure Information:

Title

Endothelial function

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rainer P Hambrecht, MD

Phone

++49-341 865

Ext

1428

hamr@medizin.uni-leipzig.de

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra Erbs, MD

Phone

++49-341 865

Ext

1428

Sandra.Erbs@medizin.uni-leipzig.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rainer P Hambrecht, MD

Organizational Affiliation

University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Leipzig, Heart Center, Department of Internal Medicine / Cardiology

City

Leipzig

State/Province

Saxony

ZIP/Postal Code

04289

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rainer P Hambrecht, MD

Phone

++49-341-865

Ext

1428

hamr@medizin.uni-leipzig.de

First Name & Middle Initial & Last Name & Degree

Sandra Erbs, MD

Phone

++49-341-865

Ext

1428

Sandra.Erbs@medizin.uni-leipzig.de

First Name & Middle Initial & Last Name & Degree

Rainer P Hambrecht, MD

12. IPD Sharing Statement

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Impact of Exercise Training on Endothelial Function in CAD

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