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Cardiovascular DiseasesHDL ProteomicsNCT00880178

Plaque Inflammation and Dysfunctional HDL in AIM-HIGH

An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington at 29 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Simvastatin and Extended-Release niacin and Simvastatin
How many people
324 participants
Where
29 sitesin 2 countries
Study dates
May 2008to Sep 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants in the main AIM-HIGH study (NCT00120289)

Who may be able to join

  • Eligible for main AIM-HIGH study (NCT00120289)
  • Willing to provide informed consent for participation in this substudy

Who cannot join

None listed.

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

United States24 sites

  • University of Maryland

    Baltimore, Maryland, 21201

  • Cardiovascular Associates

    Birmingham, Alabama, 35213

  • St. Vincent Charity Hospital

    Cleveland, Ohio, 44115

  • Duke University

    Durham, North Carolina, 27710

  • Wake Forest University, Geriatrics

    Greensboro, North Carolina, 27157

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Kelsey Research Foundation

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • Long Beach VA Medical Center

    Long Beach, California, 90822

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • HealthPartners Riverside Clinic

    Minneapolis, Minnesota, 55454

  • Christiana Care Health Services

    Newark, Delaware, 19718

  • Philadelphia VA Medical Center

    Philadelphia, Pennsylvania, 19104

  • Pennsylvania Cardiology Associates

    Philadelphia, Pennsylvania, 19106

  • Cardiology Consultants of Philadelphia

    Philadelphia, Pennsylvania, 19148

  • Cardiovascular Consultants

    Phoenix, Arizona, 85032

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Harborview Medical Center

    Seattle, Washington, 98104

  • University of Washington

    Seattle, Washington, 98105

  • Puget Sound VA Medical Center, Seattle Campus

    Seattle, Washington, 98108

  • Wake Forest University, Cardiology

    Winston-Salem, North Carolina, 27157

  • Wake Forest University, Endocrinology

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada5 sites

  • Heart Health Institute

    Calgary, Alberta, T2E-7C5

  • University of Calgary

    Calgary, Alberta, T2N-2T9

  • University of Western Ontario

    London, Ontario, N6A-5A5

  • St. Michael's Health Centre

    Toronto, Ontario, M5C-2T2

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z-1M9

Other trials in Canada

About this study

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.

Read the detailed description

CHD is the leading cause of death in the United States. Preliminary research has shown that CHD is associated with oxidative and inflammatory changes in high-density lipoprotein (HDL) cholesterol, which is considered the "good" cholesterol. The inflammatory changes can impair HDL cholesterol's normal function, which is to remove excess cholesterol from the arteries and thereby slow the build-up of atherosclerotic plaque. Statins are cholesterol-lowering medications that are used to treat people with CHD. Taking niacin, a type of B vitamin, in combination with statins may stabilize atherosclerotic plaques better than statins alone, but more research is needed to examine how niacin may do this. By improving the ability of HDL cholesterol to repair inflammatory damage to atherosclerotic plaques, niacin may assist in preventing the inflammation that leads to plaque breakdown.

The AIM-HIGH study (NCT00120289) is examining the use of niacin plus statins in people with vascular disease. Participants in the AIM-HIGH study are randomly assigned to receive either niacin plus simvastatin, which is a type of statin medication, or simvastatin alone. The purpose of this substudy is to determine whether niacin in combination with statins reduces atherosclerotic plaque inflammation and dysfunctional HDL cholesterol more than statins alone. The substudy will enroll participants who are participating in the AIM-HIGH study. At the AIM-HIGH baseline and Year 2 study visits, study researchers for this substudy will collect an additional blood sample from participants to examine the changes in HDL oxidation levels and protein composition at both time points. Study researchers will also analyze participants' MRI scans to examine changes in plaque inflammation during the study period; these MRI scans will be completed as part of another AIM-HIGH substudy, conducted by Dr. Xue-Qiao Zhao. There will be no additional study procedures or visits for participants in this substudy.

Being tested
Simvastatin and Extended-Release niacin, Simvastatin
Keywords
Simvastatin, Niacin, Vascular Disease, Magnetic Resonance Imaging, High Density Lipoprotein, Oxidation, Proteomics, Stroke, Cerebrovascular Accident
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Atherosclerosis, Myocardial Infarction, Vascular Diseases, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simvastatin and Extended-Release niacinDrug

    Also called Simvastatin/Niacin

    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.

  • SimvastatinDrug

    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.

Study groups in NCT00880178
Study groupRoleWhat they receive
SimvastatinParticipants in the main AIM-HIGH study who are receiving simvastatin.
Receives: Drug: Simvastatin
Simvastatin and Extended-Release NiacinParticipants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
Receives: Drug: Simvastatin and Extended-Release niacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HDL oxidation and proteomics

    Measured: Measured at Year 2

Secondary outcomes (4)

  1. Comparison of HDL oxidation and proteomics changes between participants receiving statins versus participants receiving statins plus niacin

    Measured: Measured at Year 2

  2. Comparison of change in an MRI marker of plaque inflammation between participants receiving statins versus participants receiving statins plus niacin

    Measured: Measured at Year 2

  3. Comparison of changes in HDL oxidation and proteomics with change in an MRI marker of plaque inflammation

    Measured: Measured at Year 2

  4. Change in an MRI marker of plaque inflammation

    Measured: Measured at Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2009 (estimated)
  2. Study startMay 2008
  3. Primary completionAug 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
324 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00880178
Sponsor's protocol ID
28201
Other IDs
R01HL089504
Acronym
HDL Proteomics
Status last verified
Feb 2018
First submitted
10 Apr 2009
Last updated
14 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25084698

  • Zhao 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.

    PubMed 25245415

  • O'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.

    PubMed 26708287

  • O'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.

    PubMed 26977429

  • Sun 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.

    PubMed 28279371

  • 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.

    PubMed 29301785

  • Ronsein 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.

    PubMed 34134520

  • Sun 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.

    PubMed 25216871

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Heart Diseases, run by University of Washington at 29 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HDL oxidation and proteomics (time frame: Measured at Year 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00880178, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.

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