Testing the hypothesis of atherosclerotic plaque lipid depletion during lipid therapy by magnetic resonance imaging: Study design of Carotid Plaque Composition Study - 16/08/11
Résumé |
Background |
In vivo testing of the lipid depletion hypothesis in human beings during lipid-modifying therapy has not been possible until recent developments in magnetic resonance imaging (MRI).
Trial Design |
The Carotid Plaque Composition Study is a prospective, randomized study designed to test the lipid depletion hypothesis in vivo. One hundred twenty-three subjects with coronary artery disease (CAD) or carotid disease and with levels of apolipoprotein B ≥120 mg/dL (low-density lipoprotein levels 100-190 mg/dL) were enrolled and randomized to (1) single therapy—atorvastatin alone, placebos for extended release (ER)–niacin and colesevelam; (2) double therapy—atorvastatin plus ER-niacin (2 g/d), and placebo for colesevelam; (3) triple therapy—atorvastatin, ER-niacin, plus colesevelam (3.8 g/d). All subjects will undergo MRI scans of bilateral carotid arteries at baseline and annually for 3 years for a total of 4 examinations while on active therapy. Among these 123 subjects with mean age of 55 years and mean body mass index of 30 kg/m2, 73% are male, 43% have a family history of premature cardiovascular disease, 37% have had a previous myocardial infarction, 80% have clinically established CAD, 52% are hypertensive, 12% have diabetes, 23% are current smokers, and 47% meet the criteria for metabolic syndrome. The baseline carotid disease is evaluated using a MRI-modified American Heart Association lesion type definition. Of the 123 enrolled subjects, 40% have type III lesions with small eccentric plaque, 52% have type IV to V lesions with a necrotic core, and only 4% have calcified plaque based on the most diseased carotid location.
Conclusions |
The Carotid Plaque Composition Study uses a state-of-the-art imaging technology and comprehensive lipid management to test the plaque lipid depletion hypothesis in CAD subjects.
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This research is supported by a National Institutes of Health grant (R01 HL63895) from the National Heart, Lung, and Blood Institute and by Pfizer Inc. The study medications are provided by Pfizer Inc, KOS Pharmaceuticals, and Daiichi-Sankyo. |
Vol 154 - N° 2
P. 239-246 - août 2007 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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