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
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Atherosclerosis
Myocardial Infarction
Drug: Simvastatin, simvastatin plus extended-release niacin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Plaque Inflammation and Dysfunctional HDL in AIM-HIGH

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in HDL oxidation and proteomics [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Plasma for HDL isolation


Enrollment: 324
Study Start Date: May 2008
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Simvastatin
Participants in the main AIM-HIGH study who are receiving simvastatin.
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 and Extended-Release Niacin
Participants in the main AIM-HIGH study who are receiving simvastatin and extended-release niacin.
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.

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 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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants in the main AIM-HIGH study (NCT00120289)

Criteria

Inclusion Criteria:

  • Eligible for main AIM-HIGH study (NCT00120289)
  • Willing to provide informed consent for participation in this substudy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00880178

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

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00880178     History of Changes
Other Study ID Numbers: 630, R01HL089504
Study First Received: April 10, 2009
Last Updated: December 18, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Simvastatin
Niacin
Vascular Disease
Magnetic Resonance Imaging
High Density Lipoprotein
Oxidation
Proteomics
Stroke
Cerebrovascular Accident

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Heart Diseases
Infarction
Inflammation
Myocardial Infarction
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Ischemia
Ischemia
Pathologic Processes
Necrosis
Niacin
Simvastatin
Nicotinic Acids
Niacinamide
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on August 19, 2014