An observational study in Coronary Artery Disease, Carotid Artery Diseases and Atherosclerosis, sponsored by University of Washington. Completed at 19 sites in 2 countries. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2018-02-09.
Sponsored by University of Washington · Observational
Heart attacks and strokes caused by the unstable atherosclerotic plaques remain the leading cause of death in the United States. Unstable plaques often have more fat than stable plaques. This study will investigate if a treatment with LDL-lowering plus HDL-raising compared with LDL-lowering alone would more effectively reduce the plaque fat content assessed by magnetic resonance imaging (MRI), therefore, further reducing heart attacks and strokes.
Although studies have suggested that plaque morphology and composition are important determinants of plaque stability, our understanding on plaque tissue components is mainly from histological studies until recent development in MRI technique. A low level of HDL is associated with higher risk of cardiovascular events and increased amount of lipid content in the carotid plaques. Treatment with LDL-lowering plus HDL-raising compared with LDL-lowering alone more effectively protects against atherosclerosis progression. It is widely believed that HDL or its apolipoproteins mediate the removal of excess free cholesterol from peripheral cells and the cholesterol is delivered via either LDL or HDL to the liver for excretion into the bile. However, it has not been tested and approved in human atherosclerotic condition in vivo. The NIH/Abbott-funded multi-center AIM-HIGH trial is designed to compare the clinical efficacy of LDL-lowering alone with statin versus LDL-lowering plus HDL-raising with statin plus nicotinic acid combination therapy in patients with established vascular disease and high triglycerides and low HDL.
We propose to conduct a carotid MRI sub-study in 220 subjects enrolled in AIM-HIGH to investigate the important vascular biological mechanisms of HDL-raising therapy. Image collection will occur at 3 timepoints. The hypotheses and specific aims are:
This MRI sub-study offers a unique opportunity to investigate the effectiveness of LDL-lowering plus HDL-raising therapy on human atherosclerotic plaque in vivo, to examine the association of plaque characteristics both lipid composition and volume assessed by MRI and cardiovascular outcome, and to gain novel insights in our understanding of atherosclerotic plaque pathology and the mechanisms of intensive lipid management in preventing cardiovascular events.
248 studies on the registry are indexed under Carotid Artery Diseases; 56 are open to participants now.
This study's enrollment of 230 is close to the median of 224 across 108 observational studies indexed under Carotid Artery Diseases.
Browse Carotid Artery Diseases studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants in the main AIM-HIGH study (NCT00120289)
Exclusion Criteria:
Participants in the main AIM-HIGH study who are receiving simvastatin.
Drug: Simvastatin, simvastatin plus extended-release niacin
Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
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.
Also known as: simvastatin, Zocor, niacin, Niaspan
Mean plaque lipid composition in carotid arteries assessed by MR
To test the primary hypothesis that compared with LDL-lowering alone, intensive LDL-lowering plus HDL-raising therapy decreases the mean plaque lipid composition in carotid arteries assessed by MRI.
Time frame: Through 24Months post AIM-HIGH Randomization
Additional plaque characteristics as assessed by MRI
To test the additional hypotheses regarding plaque burden, plaque lipid depletion time course, association with cardiovascular event risk and lipid characteristics.
Time frame: Through 24Months post AIM-HIGH Randomization
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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