Carotid Plaque Characteristics by MRI in AIM-HIGH (Carotid MRI Substudy)
2 other identifiers
observational
230
2 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFebruary 9, 2018
February 1, 2018
5.1 years
August 5, 2010
February 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Through 24Months post AIM-HIGH Randomization
Secondary Outcomes (1)
Additional plaque characteristics as assessed by MRI
Through 24Months post AIM-HIGH Randomization
Study Arms (2)
Simvastatin
Participants in the main AIM-HIGH study who are receiving simvastatin.
Simvastatin and Extended-Release Niacin
Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
Interventions
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.
Eligibility Criteria
Participants in the main AIM-HIGH study (NCT00120289)
You may qualify if:
- Eligible for main AIM-HIGH study (NCT00120289)
- Medically able to undergo MRI procedure
- Willing to provide informed consent for participation in this substudy
You may not qualify if:
- Uses pacemaker or has metallic implants
- History of bilateral carotid endarterectomy
- Glomerular filtration rate less than 60 mL/min/1.73 m\^2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Cardiovascular Consultants
Phoenix, Arizona, 85032, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
University of Southern California
Los Angeles, California, 90033, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Kelsey Research Foundation
Houston, Texas, 77030, United States
Methodist Hospital
Houston, Texas, 77030, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington
Seattle, Washington, 98105, United States
Puget Sound VA Medical Center, Seattle Campus
Seattle, Washington, 98108, United States
Heart Health Institute
Calgary, Alberta, T2E-7C5, Canada
University of Calgary
Calgary, Alberta, T2N-2T9, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z-1M9, Canada
University of Western Ontario
London, Ontario, N6A-5A5, Canada
Related Publications (6)
Hippe DS, Phan BAP, Sun J, Isquith DA, O'Brien KD, Crouse JR, Anderson T, Huston J, Marcovina SM, Hatsukami TS, Yuan C, Zhao XQ. Lp(a) (Lipoprotein(a)) Levels Predict Progression of Carotid Atherosclerosis in Subjects With Atherosclerotic Cardiovascular Disease on Intensive Lipid Therapy: An Analysis of the AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) Carotid Magnetic Resonance Imaging Substudy-Brief Report. Arterioscler Thromb Vasc Biol. 2018 Mar;38(3):673-678. doi: 10.1161/ATVBAHA.117.310368. Epub 2018 Jan 4.
PMID: 29301785RESULTSun J, Zhao XQ, Balu N, Hippe DS, Hatsukami TS, Isquith DA, Yamada K, Neradilek MB, Canton G, Xue Y, Fleg JL, Desvigne-Nickens P, Klimas MT, Padley RJ, Vassileva MT, Wyman BT, Yuan C. Carotid magnetic resonance imaging for monitoring atherosclerotic plaque progression: a multicenter reproducibility study. Int J Cardiovasc Imaging. 2015 Jan;31(1):95-103. doi: 10.1007/s10554-014-0532-7. Epub 2014 Sep 13.
PMID: 25216871RESULTChen H, Sun J, Kerwin WS, Balu N, Neradilek MB, Hippe DS, Isquith D, Xue Y, Yamada K, Peck S, Yuan C, O'Brien KD, Zhao XQ. Scan-rescan reproducibility of quantitative assessment of inflammatory carotid atherosclerotic plaque using dynamic contrast-enhanced 3T CMR in a multi-center study. J Cardiovasc Magn Reson. 2014 Aug 1;16(1):51. doi: 10.1186/s12968-014-0051-7.
PMID: 25084698RESULTZhao XQ, Hatsukami TS, Hippe DS, Sun J, Balu N, Isquith DA, Crouse JR 3rd, Anderson T, Huston J 3rd, Polissar N, O'Brien K, Yuan C; AIM-HIGH Carotid MRI Sub-study Investigators. Clinical factors associated with high-risk carotid plaque features as assessed by magnetic resonance imaging in patients with established vascular disease (from the AIM-HIGH Study). Am J Cardiol. 2014 Nov 1;114(9):1412-9. doi: 10.1016/j.amjcard.2014.08.001. Epub 2014 Aug 13.
PMID: 25245415RESULTZhao XQ, Sun J, Hippe DS, Isquith DA, Canton G, Yamada K, Balu N, Crouse JR 3rd, Anderson TJ, Huston J 3rd, O'Brien KD, Hatsukami TS, Yuan C; AIM-HIGH Carotid MRI Substudy Investigators. Magnetic Resonance Imaging of Intraplaque Hemorrhage and Plaque Lipid Content With Continued Lipid-Lowering Therapy: Results of a Magnetic Resonance Imaging Substudy in AIM-HIGH. Circ Cardiovasc Imaging. 2022 Nov;15(11):e014229. doi: 10.1161/CIRCIMAGING.122.014229. Epub 2022 Nov 15.
PMID: 36378778DERIVEDO'Brien KD, Hippe DS, Chen H, Neradilek MB, Probstfield JL, Peck S, Isquith DA, Canton G, Yuan C, Polissar NL, Zhao XQ, Kerwin WS. Longer duration of statin therapy is associated with decreased carotid plaque vascularity by magnetic resonance imaging. Atherosclerosis. 2016 Feb;245:74-81. doi: 10.1016/j.atherosclerosis.2015.11.032. Epub 2015 Dec 1.
PMID: 26708287DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xue-Qiao Zhao, MD
University of Washington
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 10, 2010
Study Start
March 1, 2008
Primary Completion
April 1, 2013
Study Completion
February 1, 2015
Last Updated
February 9, 2018
Record last verified: 2018-02