Plaque Inflammation and Dysfunctional HDL in AIM-HIGH
HDL Proteomics
2 other identifiers
observational
324
2 countries
29
Brief Summary
Coronary heart disease (CHD) is a serious health concern that affects millions of people in the United States. It is usually caused by atherosclerosis-a condition that occurs when fatty material and plaque build up on the walls of the arteries that supply blood and oxygen to the heart, causing the arteries to narrow. As the arteries narrow, blood flow to the heart can slow down or stop, which can cause chest pain, shortness of breath, heart attack, or heart failure. Another component of CHD events involves inflammatory changes that result in structural breakdown of atherosclerotic plaques. Adding niacin to statin medications may be an effective way to block inflammation in the atherosclerotic plaques. This study will examine magnetic resonance imaging (MRI) images and blood samples of participants in the AIM-HIGH study who are taking niacin plus statins or statins alone to determine the effect of these medications on inflammation in atherosclerotic plaques.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Typical duration for all trials
29 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
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedMay 14, 2018
February 1, 2018
3.3 years
April 10, 2009
May 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HDL oxidation and proteomics
Measured at Year 2
Secondary Outcomes (4)
Comparison of HDL oxidation and proteomics changes between participants receiving statins versus participants receiving statins plus niacin
Measured at Year 2
Comparison of change in an MRI marker of plaque inflammation between participants receiving statins versus participants receiving statins plus niacin
Measured at Year 2
Comparison of changes in HDL oxidation and proteomics with change in an MRI marker of plaque inflammation
Measured at Year 2
Change in an MRI marker of plaque inflammation
Measured at Year 2
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.
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)
- Willing to provide informed consent for participation in this substudy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Cardiovascular Associates
Birmingham, Alabama, 35213, United States
Cardiovascular Consultants
Phoenix, Arizona, 85032, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Christiana Care Health Services
Newark, Delaware, 19718, United States
University of Maryland
Baltimore, Maryland, 21201, United States
University of Minnesota
Minneapolis, Minnesota, 55414, United States
HealthPartners Riverside Clinic
Minneapolis, Minnesota, 55454, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Duke University
Durham, North Carolina, 27710, United States
Wake Forest University, Geriatrics
Greensboro, North Carolina, 27157, United States
Wake Forest University, Cardiology
Winston-Salem, North Carolina, 27157, United States
Wake Forest University, Endocrinology
Winston-Salem, North Carolina, 27157, United States
St. Vincent Charity Hospital
Cleveland, Ohio, 44115, United States
Portland VA Medical Center
Portland, Oregon, 97239, United States
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Cardiology Associates
Philadelphia, Pennsylvania, 19106, United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19148, 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
McGuire VA Medical Center
Richmond, Virginia, 23249, 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
St. Michael's Health Centre
Toronto, Ontario, M5C-2T2, Canada
Related Publications (8)
Chen 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: 25245415RESULTO'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: 26708287RESULTO'Brien KD, Hippe DS, Chen H, Neradilek MB, Probstfield JL, Peck S, Isquith DA, Canton G, Yuan C, Polissar NL, Zhao XQ, Kerwin WS. Summary of clinical and laboratory data of study subjects with and without DCE-MRI plaque measurements in the AIM-HIGH clinical trial. Data Brief. 2016 Jan 2;6:476-81. doi: 10.1016/j.dib.2015.12.030. eCollection 2016 Mar.
PMID: 26977429RESULTSun J, Zhao XQ, Balu N, Neradilek MB, Isquith DA, Yamada K, Canton G, Crouse JR 3rd, Anderson TJ, Huston J 3rd, O'Brien K, Hippe DS, Polissar NL, Yuan C, Hatsukami TS. Carotid Plaque Lipid Content and Fibrous Cap Status Predict Systemic CV Outcomes: The MRI Substudy in AIM-HIGH. JACC Cardiovasc Imaging. 2017 Mar;10(3):241-249. doi: 10.1016/j.jcmg.2016.06.017.
PMID: 28279371RESULTHippe 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: 29301785RESULTRonsein GE, Vaisar T, Davidson WS, Bornfeldt KE, Probstfield JL, O'Brien KD, Zhao XQ, Heinecke JW. Niacin Increases Atherogenic Proteins in High-Density Lipoprotein of Statin-Treated Subjects. Arterioscler Thromb Vasc Biol. 2021 Aug;41(8):2330-2341. doi: 10.1161/ATVBAHA.121.316278. Epub 2021 Jun 17.
PMID: 34134520DERIVEDSun 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: 25216871DERIVED
Biospecimen
Plasma for HDL isolation
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin D. O'Brien, 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 of Medicine, Cardiology
Study Record Dates
First Submitted
April 10, 2009
First Posted
April 13, 2009
Study Start
May 1, 2008
Primary Completion
August 1, 2011
Study Completion
September 1, 2011
Last Updated
May 14, 2018
Record last verified: 2018-02