Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Coronary Artery Disease (HERCET-Study)

Coronary Artery Disease Clinical Trial

— HERCET  

Official title:

Randomized, Clinical Trial to Study the Effect of Exercise Training on the Function of HDL-Cholesterol, Endothelial Function, Oxidative Stress and Regenerative Capacity of Endothelial Progenitor Cells in Patients With Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00457379
• Other study ID #: 4031214
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2007
• Last updated: August 14, 2007
• Start date: April 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2007
• Source: Hannover Medical School
• Contact: Ulf Landmesser, MD
• Phone: +49511532
• Email: Landmesser.Ulf[@]MH-Hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Patients with coronary artery disease are characterized by an increased cardiovascular risk and they often have low blood high density lipoprotein (HDL)-cholesterol levels or HDL-cholesterol with modified vasculoprotective properties.

The purpose of the present study is to characterize the quality of HDL-cholesterol in patients with coronary artery disease and normal blood HDL-cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-cholesterol in these patients. Additionally, the researchers aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with coronary artery disease and the changes dependent on physical activity of patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Coronary artery disease

• Normal HDL-cholesterol levels in blood:

• > 40 mg/dl (1.03 mmol/L) in males

• > 50 mg/dl (1.29 mmol/L) in females

Exclusion Criteria:

• Type 1 or 2 diabetes mellitus

• Acute coronary syndrome

• Unstable angina pectoris

• Myocardial infarction during the last 8 weeks

• Therapy with niacin

• Active infections

• Ventricular arrhythmias

• Systolic blood pressure > 160 mmHg or diastolic blood pressure > 95 mmHg

• Cancer

• Pregnant or lactating

• Alcoholism

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Behavioral:
• physical exercise

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training
Secondary	flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound