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Plaque Inflammation and Dysfunctional HDL Cholesterol in Participants Receiving Niacin and Statins in the AIM-HIGH Study (The HDL Proteomics Study)
This study is currently recruiting participants.
Verified by National Heart, Lung, and Blood Institute (NHLBI), April 2009
First Received: April 10, 2009   No Changes Posted
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00880178
  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: Cohort, Prospective
Official Title: Plaque Inflammation and Dysfunctional HDL in AIM-HIGH

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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

Biospecimen Description:

Plasma for HDL isolation


Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880178

Contacts
Contact: Suzanne Peck 206-221-7974 suzannep@cardiology.washington.edu
Contact: Kevin D. O'Brien, MD 206-685-3930 cardiac@u.washington.edu

  Show 29 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Kevin D. O'Brien, MD University of Washington
  More Information

No publications provided

Responsible Party: University of Washington ( Kevin D. O'Brien, MD )
Study ID Numbers: 630, R01 HL089504
Study First Received: April 10, 2009
Last Updated: April 10, 2009
ClinicalTrials.gov Identifier: NCT00880178     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Simvastatin
Niacin
Vascular Disease
Magnetic Resonance Imaging
High Density Lipoprotein
Oxidation
Proteomics
Stroke
Cerebrovascular Accident

Study placed in the following topic categories:
Atherosclerosis
Antimetabolites
Vasodilator Agents
Niacinamide
Cerebral Infarction
Myocardial Ischemia
Arteriosclerosis
Nicotinamide
Nicotinic Acids
Necrosis
Vitamins
Micronutrients
Nicotinic Acid
Myocardial Infarction
Arterial Occlusive Diseases
Vitamin B Complex
Heart Diseases
Simvastatin
Antilipemic Agents
Stroke
Vascular Diseases
Trace Elements
Anticholesteremic Agents
Ischemia
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Inflammation
Coronary Disease
Vitamin B3
Infarction

Additional relevant MeSH terms:
Atherosclerosis
Antimetabolites
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Arteriosclerosis
Necrosis
Pathologic Processes
Vitamins
Therapeutic Uses
Cardiovascular Diseases
Micronutrients
Myocardial Infarction
Arterial Occlusive Diseases
Heart Diseases
Vitamin B Complex
Simvastatin
Growth Substances
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Anticholesteremic Agents
Ischemia
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Inflammation
Coronary Disease
Infarction

ClinicalTrials.gov processed this record on September 04, 2009