Coronary Disease Clinical Trial
Official title:
Exercise Versus Extended-Release Niacin in Patients With Coronary Heart Disease and Low High-Density Lipoproteins (HDL) Cholesterol: Effect on Lipid Profile and Endothelial Function
The investigators want to study the relative effects of physical exercise vs.
extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and
low HDL cholesterol ("good cholesterol") on
- lipid profile
- endothelial function as measured by ultrasound
The endothelium is the inner part of the blood vessels. Impaired endothelial function is
known to be associated with atherosclerosis which can ultimately lead to diseases such as
stroke, heart attack and others. Endothelial function can be assessed non-invasively by
ultrasound.
Both interventions mentioned above have been shown to have a beneficial effect on lipid
profile and endothelial function. However, the relative effects are unclear.
Status | Completed |
Enrollment | 48 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Coronary disease - Low HDL cholesterol - Age limits (see below) Exclusion Criteria: - Unstable angina oder MI within 3 months prior to inclusion - CAD with indication for bypass surgery - Left main disease ( > 25% stenosis diameter) - Ejection fraction < 40% - Higher degree heart valve disease - Higher degree ventricular arrhythmias - Type 1 Diabetes - Severe disorders of lipoprotein metabolism (Low-density lipoprotein cholesterol (LDL)> 5.0 mmol/L) - Severe liver disease - Thyroid disease - Alcohol or drug abuse - Pregnancy - Stroke or Transient Ischemic Attack (TIA) within 3 months prior to inclusion - Allergy against niacin oder other ingredient of niaspan - Participation in other clinical trial within 30 days prior to inclusion - Acute gastric ulcer - Arterial bleeding - Uncontrolled severe arterial hypertension - Treatment with lipid-lowering drug other than Hydroxy-Methylglutaryl Coenzyme A (HMG-CoA)-inhibitor within 3 months prior to inclusion |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University of Leipzig Heart Center | Leipzig |
Lead Sponsor | Collaborator |
---|---|
University of Leipzig |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | relative effect on flow-mediated dilatation of radial artery | 6 months | No | |
Secondary | lipid profile | 6 months | No | |
Secondary | biochemical markers of atherosclerosis | 6 months | No | |
Secondary | expression of monocyte surface markers | 6 months | No | |
Secondary | oxidative stress | 6 months | No | |
Secondary | thrombogenicity | 6 months | No |
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