Plaque Inflammation and Dysfunctional HDL in AIM-HIGH
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 5/16/2018 |
| Start Date: | May 2008 |
| End Date: | September 2011 |
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.
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.
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 simvastatin, which is a type of statin medication, or simvastatin 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.
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 simvastatin, which is a type of statin medication, or simvastatin 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.
Inclusion Criteria:
- Eligible for main AIM-HIGH study (NCT00120289)
- Willing to provide informed consent for participation in this substudy
We found this trial at
25
sites
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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