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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00035711 |
To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention Trial (VA-HIT).
Condition |
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Coronary Disease Heart Diseases Cardiovascular Diseases Carotid Artery Diseases Diabetes Mellitus, Non-Insulin Dependent Hypertension Insulin Resistance Obesity Diabetes Mellitus |
Study Type: | Observational |
Study Design: | Defined Population, Retrospective Study |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | August 2004 |
BACKGROUND:
The VA HDL Intervention trial (VA-HIT) was a multicenter, placebo controlled, randomized trial that showed that gemfibrozil significantly reduced major cardiovascular events in 2531 men with coronary heart disease, low levels of low density lipoprotein (LDL) cholesterol and low levels of high density lipoprotein (HDL) cholesterol. In addition to its unique lipid profile, the VA-HIT population also had a high prevalence of diabetes, impaired fasting glucose, or high fasting plasma insulin; central obesity; and hypertension, which are all components (together with high triglycerides and low HDL-cholesterol) of a constellation of risk factors known as the metabolic syndrome. Since prior clinical trials have not enrolled this type of population, the VA- HIT database is a unique resource.
DESIGN NARRATIVE:
The study used the VA-HIT database to study additional risk markers that were measured in the study population of 2,531 men with coronary heart disease. Specific analyses were: 1) the association between levels of glucose tolerance, insulin resistance and other features of the metabolic syndrome, occurrence of major cardiovascular outcomes, and gemfibrozil efficacy; 2) the effect of gemfibrozil on progression of carotid atherosclerosis, as measured by B-mode ultrasound; 3) the association between LDL particle size distribution and lipoprotein subclass distribution; homocysteine; lipoprotein(a); C-reactive protein, tissue plasminogen activator; fibrinogen; and factor VII; major cardiovascular outcomes and gemfibrozil efficacy.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
No eligibility criteria
Study ID Numbers: | 1008 |
Study First Received: | May 4, 2002 |
Last Updated: | November 10, 2005 |
ClinicalTrials.gov Identifier: | NCT00035711 |
Health Authority: | United States: Federal Government |
Myocardial Ischemia Overweight Arteriosclerosis Brain Diseases Cerebrovascular Disorders Body Weight Signs and Symptoms Hyperinsulinism Nutrition Disorders Arterial Occlusive Diseases Obesity Heart Diseases Metabolic Diseases Vascular Diseases |
Diabetes Mellitus Central Nervous System Diseases Endocrine System Diseases Ischemia Coronary Disease Diabetes Mellitus, Type 2 Overnutrition Endocrinopathy Insulin Resistance Metabolic disorder Carotid Artery Diseases Glucose Metabolism Disorders Coronary Artery Disease Hypertension |
Nervous System Diseases Cardiovascular Diseases |