Plaque Inflammation and Dysfunctional HDL Cholesterol in Participants Receiving Niacin and Statins in the AIM-HIGH Study (The HDL Proteomics Study) - NCT00880178-44115 (Clinical Trial 283741)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy283741.aspx
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| City: |
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Cleveland |
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State:
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OH |
| Zip Code: |
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44115 |
| Conditions: |
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Cardiovascular Diseases - Heart Diseases - Coronary Disease - Atherosclerosis - Myocardial Infarction |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- Eligible for main AIM-HIGH study (NCT00120289)
- Willing to provide informed consent for participation in this substudy |
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| Study is available at: |
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St. Vincent Charity Hospital
Cleveland, OH 44115
United States
Primary Contact:
Mariellen DeSmit
Phone: 216-363-2732
Secondary Contact:
Suzanne Peck
Email: suzannep@cardiology.washington.edu
Phone: 206-221-7974 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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