Plaque Inflammation and Dysfunctional HDL Cholesterol in Participants Receiving Niacin and Statins in the AIM-HIGH Study (The HDL Proteomics Study)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00880178
First received: April 10, 2009
Last updated: December 18, 2012
Last verified: December 2012

April 10, 2009
December 18, 2012
May 2008
August 2011   (final data collection date for primary outcome measure)
Change in HDL oxidation and proteomics [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00880178 on ClinicalTrials.gov Archive Site
  • Comparison of HDL oxidation and proteomics changes between participants receiving statins versus participants receiving statins plus niacin [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Comparison of change in Ktrans MRI marker of plaque inflammation between participants receiving statins versus participants receiving statins plus niacin [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Comparison of changes in HDL oxidation and proteomics with change in Ktrans MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
  • Change in Ktrans MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Plaque Inflammation and Dysfunctional HDL Cholesterol in Participants Receiving Niacin and Statins in the AIM-HIGH Study (The HDL Proteomics Study)
Plaque Inflammation and Dysfunctional HDL in AIM-HIGH

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.

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 simvastain, which is a type of statin medication, or simvastain 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma for HDL isolation

Probability Sample

Participants in the main AIM-HIGH study (NCT00120289)

  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Atherosclerosis
  • Myocardial Infarction
Drug: Simvastatin, simvastatin plus extended-release 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.
  • Simvastatin
    Participants in the main AIM-HIGH study who are receiving simvastatin.
    Intervention: Drug: Simvastatin, simvastatin plus extended-release niacin
  • Simvastatin and Extended-Release Niacin
    Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
    Intervention: Drug: Simvastatin, simvastatin plus extended-release niacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
324
September 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible for main AIM-HIGH study (NCT00120289)
  • Willing to provide informed consent for participation in this substudy
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00880178
630, R01HL089504
Yes
University of Washington
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Kevin D. O'Brien, MD University of Washington
University of Washington
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP