Carotid Plaque Characteristics by MRI in AIM-HIGH (Carotid MRI Substudy)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:2/11/2018
Start Date:March 2008
End Date:February 2015

Use our guide to learn which trials are right for you!

Carotid Plaque Characteristics by MRI in AIM-HIGH

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:

- (1) 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.

- (2) To test the hypothesis that compared with LDL-lowering alone, intensive LDL-lowering
plus HDL-raising therapy decreases the plaque burden including volume and wall
thickness.

- (3) To test the hypothesis that increased plaque lipid composition or vessel wall
thickness by MRI is associated with increased risk of cardiovascular events.

- (4)To test a hypothesis that LDL-lowering plus HDL-raising, compared to LDL-lowering
alone, will promote more rapid plaque lipid depletion. And determine the time-course of
atherosclerotic plaque lipid depletion during lipid therapy.

- (5) To examine the association of clinical risk factors, lipids, lipoprotein
heterogeneity, inflammatory markers and carotid plaque characteristics.

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.

Inclusion Criteria:

- Eligible for main AIM-HIGH study (NCT00120289)

- Medically able to undergo MRI procedure

- Willing to provide informed consent for participation in this substudy

Exclusion Criteria:

- Uses pacemaker or has metallic implants

- History of bilateral carotid endarterectomy

- Glomerular filtration rate less than 60 mL/min/1.73 m^2
We found this trial at
16
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
5615 Kirby Dr.
Houston, Texas 77005
713-442-1223
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Long Beach, California 90822
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85032
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials