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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hannover Medical School.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00457379
First received: April 4, 2007
Last updated: August 14, 2007
Last verified: April 2007
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Behavioral: physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • vasculoprotective and regenerative functions of HDL-cholesterol before and after 8-weeks of exercise training

Secondary Outcome Measures:
  • flow-mediated, endothelium-dependent vasodilation of radial artery measured by ultrasound

Estimated Enrollment: 30
Study Start Date: April 2007
Estimated Study Completion Date: April 2008
  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457379

Contacts
Contact: Ulf Landmesser, MD +49511532 ext 2229 Landmesser.Ulf@MH-Hannover.de
Contact: Kristina Sonnenschein +49511532 ext 5402 Sonnenschein.Kristina@MH-Hannover.de

Locations
Germany
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Ulf Landmesser, MD     +49511532 ext 2229     Ulf.Landmesser@MH-Hannover.de    
Contact: Kristina Sonnenschein     +49511532 ext 5402     Sonnenschein.Kristina@MH-Hannover.de    
Principal Investigator: Ulf Landmesser, MD            
Sponsors and Collaborators
Hannover Medical School
Investigators
Study Director: Helmut Drexler, MD Hannover Medical School
Principal Investigator: Ulf Landmesser, MD Hannover Medical School
Principal Investigator: Kristina Sonnenschein, MD Hannover Medical School
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00457379     History of Changes
Other Study ID Numbers: 4031214
Study First Received: April 4, 2007
Last Updated: August 14, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Coronary artery disease
HDL-Cholesterol
Endothelial Function
Endothelial Progenitor Cells
normal blood HDL-Cholesterol level

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013