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

May 8, 2018 updated by: Kevin O'Brien, University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2E-7C5
        • Heart Health Institute
      • Calgary, Alberta, Canada, T2N-2T9
        • University of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z-1M9
        • Vancouver General Hospital
    • Ontario
      • London, Ontario, Canada, N6A-5A5
        • University of Western Ontario
      • Toronto, Ontario, Canada, M5C-2T2
        • St. Michael's Health Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Cardiovascular Associates
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Cardiovascular Consultants
    • California
      • Long Beach, California, United States, 90822
        • Long Beach VA Medical Center
    • Delaware
      • Newark, Delaware, United States, 19718
        • Christiana Care Health Services
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • HealthPartners Riverside Clinic
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Greensboro, North Carolina, United States, 27157
        • Wake Forest University, Geriatrics
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University, Cardiology
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University, Endocrinology
    • Ohio
      • Cleveland, Ohio, United States, 44115
        • St. Vincent Charity Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center
      • Philadelphia, Pennsylvania, United States, 19148
        • Cardiology Consultants of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19106
        • Pennsylvania Cardiology Associates
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Methodist Hospital
      • Houston, Texas, United States, 77030
        • Kelsey Research Foundation
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98105
        • University of Washington
      • Seattle, Washington, United States, 98108
        • Puget Sound VA Medical Center, Seattle Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants in the main AIM-HIGH study (NCT00120289)

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Simvastatin
Participants in the main AIM-HIGH study who are receiving simvastatin.
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.
Simvastatin and Extended-Release Niacin
Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
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 Names:
  • Simvastatin/Niacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HDL oxidation and proteomics
Time Frame: Measured at Year 2
Measured at Year 2

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of HDL oxidation and proteomics changes between participants receiving statins versus participants receiving statins plus niacin
Time Frame: Measured at Year 2
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
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
Measured at Year 2
Change in an MRI marker of plaque inflammation
Time Frame: Measured at Year 2
Measured at Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Kevin D. O'Brien, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 10, 2009

First Posted (Estimate)

April 13, 2009

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28201
  • R01HL089504 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Simvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe