Testing the hypothesis of atherosclerotic plaque lipid depletion during lipid therapy by magnetic resonance imaging: Study design of Carotid Plaque Composition Study

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 l...

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Published in:The American heart journal 2007-08, Vol.154 (2), p.239-246
Main Authors: Zhao, Xue-Qiao, MD, Phan, Binh An P., MD, Chu, Baocheng, MD, PhD, Bray, Frank, BS, Moore, Andrew B., BS, Polissar, Nayak L., PhD, Dodge, J. Theodore, MD, Lee, Colin D., MD, Hatsukami, Thomas S., MD, Yuan, Chun, PhD
Format: Article
Language:English
Subjects:
Allylamine - analogs & derivatives
Allylamine - pharmacology
Allylamine - therapeutic use
Atherosclerosis
Atherosclerosis (general aspects, experimental research)
Atherosclerosis - diagnosis
Atherosclerosis - drug therapy
Atorvastatin Calcium
Biological and medical sciences
Blood and lymphatic vessels
Cardiology. Vascular system
Cardiovascular
Cardiovascular disease
Carotid Stenosis - diagnosis
Carotid Stenosis - drug therapy
Cholesterol
Colesevelam Hydrochloride
Double-Blind Method
Female
Heptanoic Acids - pharmacology
Heptanoic Acids - therapeutic use
Humans
Hypolipidemic Agents - pharmacology
Hypolipidemic Agents - therapeutic use
Hypotheses
Lipid Metabolism - drug effects
Lipids
Lipoproteins
Magnetic Resonance Imaging
Male
Medical sciences
Middle Aged
Niacin - pharmacology
Niacin - therapeutic use
NMR
Nuclear magnetic resonance
Prospective Studies
Pyrroles - pharmacology
Pyrroles - therapeutic use
Studies
Triglycerides
Vitamin B
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Summary: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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2007.04.035