Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plaque Inflammation and Dysfunctional HDL in AIM-HIGH (HDL Proteomics)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00880178
Recruitment Status : Completed
First Posted : April 13, 2009
Last Update Posted : May 14, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Kevin O'Brien, University of Washington

Tracking Information
First Submitted Date April 10, 2009
First Posted Date April 13, 2009
Last Update Posted Date May 14, 2018
Study Start Date May 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 10, 2009)
Change in HDL oxidation and proteomics [ Time Frame: Measured at Year 2 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 12, 2017)
  • Comparison of HDL oxidation and proteomics changes between participants receiving statins versus participants receiving statins plus niacin [ Time Frame: Measured at Year 2 ]
  • Comparison of change in an MRI marker of plaque inflammation between participants receiving statins versus participants receiving statins plus niacin [ Time Frame: Measured at Year 2 ]
  • Comparison of changes in HDL oxidation and proteomics with change in an MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ]
  • Change in an MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ]
Original Secondary Outcome Measures
 (submitted: April 10, 2009)
  • Comparison of HDL oxidation and proteomics changes between participants receiving statins versus participants receiving statins plus niacin [ Time Frame: Measured at Year 2 ]
  • 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 ]
  • Comparison of changes in HDL oxidation and proteomics with change in Ktrans MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ]
  • Change in Ktrans MRI marker of plaque inflammation [ Time Frame: Measured at Year 2 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Plaque Inflammation and Dysfunctional HDL in AIM-HIGH
Official Title Plaque Inflammation and Dysfunctional HDL in AIM-HIGH
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma for HDL isolation
Sampling Method Probability Sample
Study Population Participants in the main AIM-HIGH study (NCT00120289)
Condition
  • Cardiovascular Diseases
  • Heart Diseases
  • Coronary Disease
  • Atherosclerosis
  • Myocardial Infarction
Intervention
  • Drug: Simvastatin and 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.
    Other Name: Simvastatin/Niacin
  • Drug: Simvastatin
    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/Cohorts
  • Simvastatin
    Participants in the main AIM-HIGH study who are receiving simvastatin.
    Intervention: Drug: Simvastatin
  • Simvastatin and Extended-Release Niacin
    Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
    Intervention: Drug: Simvastatin and Extended-Release niacin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 23, 2012)
324
Original Estimated Enrollment
 (submitted: April 10, 2009)
200
Actual Study Completion Date September 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Eligible for main AIM-HIGH study (NCT00120289)
  • Willing to provide informed consent for participation in this substudy
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00880178
Other Study ID Numbers 28201
R01HL089504 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kevin O'Brien, University of Washington
Study Sponsor University of Washington
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Kevin D. O'Brien, MD University of Washington
PRS Account University of Washington
Verification Date February 2018