NCT00176345

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

September 15, 2005

Status Verified

September 1, 2005

First QC Date

September 11, 2005

Last Update Submit

September 11, 2005

Conditions

Coronary Artery Disease

Keywords

exercise trainingendothelial function

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

Interventions

Exercise TrainingBEHAVIORAL

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable CAD
  • male gender

You may not qualify if:

  • insulin-dependent diabetes mellitus
  • significant valvular heart disease
  • smoking
  • exercise-induced myocardial ischemia
  • conditions prohibiting exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Leipzig, Saxony, 04289, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rainer P Hambrecht, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rainer P Hambrecht, MD

CONTACT

++49-341 865hamr@medizin.uni-leipzig.de

Sandra Erbs, MD

CONTACT

++49-341 865Sandra.Erbs@medizin.uni-leipzig.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 15, 2005

Study Start

January 1, 2001

Last Updated

September 15, 2005

Record last verified: 2005-09

Locations

DE(1)