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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: | NCT00880178 |
Coronary heart disease (CHD) is a serious health concern that affects millions of people in the United States. It is usually caused by atherosclerosis—a condition that occurs when fatty material and plaque build up on the walls of the arteries that supply blood and oxygen to the heart, causing the arteries to narrow. As the arteries narrow, blood flow to the heart can slow down or stop, which can cause chest pain, shortness of breath, heart attack, or heart failure. Another component of CHD events involves inflammatory changes that result in structural breakdown of atherosclerotic plaques. Adding niacin to statin medications may be an effective way to block inflammation in the atherosclerotic plaques. This study will examine magnetic resonance imaging (MRI) images and blood samples of participants in the AIM-HIGH study who are taking niacin plus statins or statins alone to determine the effect of these medications on inflammation in atherosclerotic plaques.
Condition | Intervention |
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Cardiovascular Diseases Heart Diseases Coronary Disease Atherosclerosis Myocardial Infarction |
Drug: Simvastatin, simvastatin plus extended-release niacin |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Plaque Inflammation and Dysfunctional HDL in AIM-HIGH |
Plasma for HDL isolation
Estimated Enrollment: | 200 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Simvastatin
Participants in the main AIM-HIGH study who are receiving simvastatin.
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Drug: Simvastatin, simvastatin plus extended-release niacin
Participants will be enrolled in this substudy only if they are candidates for the main AIM-HIGH study (NCT00120289). Participants will be randomly assigned to simvastatin or simvastatin plus niacin as a part of the main AIM-HIGH protocol, and adjustments in simvastatin and/or niacin doses will be made as per the protocol for the main AIM-HIGH study.
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Simvastatin and Extended-Release Niacin
Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
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Drug: Simvastatin, simvastatin plus extended-release niacin
Participants will be enrolled in this substudy only if they are candidates for the main AIM-HIGH study (NCT00120289). Participants will be randomly assigned to simvastatin or simvastatin plus niacin as a part of the main AIM-HIGH protocol, and adjustments in simvastatin and/or niacin doses will be made as per the protocol for the main AIM-HIGH study.
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CHD is the leading cause of death in the United States. Preliminary research has shown that CHD is associated with oxidative and inflammatory changes in high-density lipoprotein (HDL) cholesterol, which is considered the "good" cholesterol. The inflammatory changes can impair HDL cholesterol's normal function, which is to remove excess cholesterol from the arteries and thereby slow the build-up of atherosclerotic plaque. Statins are cholesterol-lowering medications that are used to treat people with CHD. Taking niacin, a type of B vitamin, in combination with statins may stabilize atherosclerotic plaques better than statins alone, but more research is needed to examine how niacin may do this. By improving the ability of HDL cholesterol to repair inflammatory damage to atherosclerotic plaques, niacin may assist in preventing the inflammation that leads to plaque breakdown.
The AIM-HIGH study (NCT00120289) is examining the use of niacin plus statins in people with vascular disease.
Participants in the AIM-HIGH study are randomly assigned to receive either niacin plus simvastain, which is a type of statin medication, or simvastain alone. The purpose of this substudy is to determine whether niacin in combination with statins reduces atherosclerotic plaque inflammation and dysfunctional HDL cholesterol more than statins alone. The substudy will enroll participants who are participating in the AIM-HIGH study. At the AIM-HIGH baseline and Year 2 study visits, study researchers for this substudy will collect an additional blood sample from participants to examine the changes in HDL oxidation levels and protein composition at both time points.
Study researchers will also analyze participants' MRI scans to examine changes in plaque inflammation during the study period; these MRI scans will be completed as part of another AIM-HIGH substudy, conducted by Dr. Xue-Qiao Zhao. There will be no additional study procedures or visits for participants in this substudy.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Participants in the main AIM-HIGH study (NCT00120289)
Inclusion Criteria:
Contact: Suzanne Peck | 206-221-7974 | suzannep@cardiology.washington.edu |
Contact: Kevin D. O'Brien, MD | 206-685-3930 | cardiac@u.washington.edu |
Principal Investigator: | Kevin D. O'Brien, MD | University of Washington |
Responsible Party: | University of Washington ( Kevin D. O'Brien, MD ) |
Study ID Numbers: | 630, R01 HL089504 |
Study First Received: | April 10, 2009 |
Last Updated: | April 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00880178 History of Changes |
Health Authority: | United States: Federal Government |
Simvastatin Niacin Vascular Disease Magnetic Resonance Imaging High Density Lipoprotein |
Oxidation Proteomics Stroke Cerebrovascular Accident |
Atherosclerosis Antimetabolites Vasodilator Agents Niacinamide Cerebral Infarction Myocardial Ischemia Arteriosclerosis Nicotinamide Nicotinic Acids Necrosis Vitamins Micronutrients Nicotinic Acid Myocardial Infarction Arterial Occlusive Diseases |
Vitamin B Complex Heart Diseases Simvastatin Antilipemic Agents Stroke Vascular Diseases Trace Elements Anticholesteremic Agents Ischemia Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Inflammation Coronary Disease Vitamin B3 Infarction |
Atherosclerosis Antimetabolites Vasodilator Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Arteriosclerosis Necrosis Pathologic Processes Vitamins Therapeutic Uses Cardiovascular Diseases Micronutrients Myocardial Infarction Arterial Occlusive Diseases |
Heart Diseases Vitamin B Complex Simvastatin Growth Substances Antilipemic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Ischemia Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Inflammation Coronary Disease Infarction |