Trial record 2 of 3 for:    NCT00120289

Carotid Plaque Characteristics by MRI in AIM-HIGH (Carotid MRI Substudy)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Xue-Qiao Zhao, University of Washington
ClinicalTrials.gov Identifier:
NCT01178320
First received: August 5, 2010
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

Heart attacks and strokes caused by the unstable atherosclerotic plaques remain the leading cause of death in the United States. Unstable plaques often have more fat than stable plaques. This study will investigate if a treatment with LDL-lowering plus HDL-raising compared with LDL-lowering alone would more effectively reduce the plaque fat content assessed by magnetic resonance imaging (MRI), therefore, further reducing heart attacks and strokes.


Condition Intervention
Coronary Artery Disease
Carotid Artery Diseases
Atherosclerosis
Drug: Simvastatin, simvastatin plus extended-release niacin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Carotid Plaque Characteristics by MRI in AIM-HIGH

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Mean plaque lipid composition in carotid arteries assessed by MR [ Time Frame: Through 24Months post AIM-HIGH Randomization ] [ Designated as safety issue: No ]
    To test the primary hypothesis that compared with LDL-lowering alone, intensive LDL-lowering plus HDL-raising therapy decreases the mean plaque lipid composition in carotid arteries assessed by MRI.


Secondary Outcome Measures:
  • Additional plaque characteristics as assessed by MRI [ Time Frame: Through 24Months post AIM-HIGH Randomization ] [ Designated as safety issue: No ]
    To test the additional hypotheses regarding plaque burden, plaque lipid depletion time course, association with cardiovascular event risk and lipid characteristics.


Enrollment: 230
Study Start Date: March 2008
Estimated Study Completion Date: February 2015
Primary Completion Date: April 2013 (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.
Other Names:
  • simvastatin
  • Zocor
  • niacin
  • Niaspan
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.
Other Names:
  • simvastatin
  • Zocor
  • niacin
  • Niaspan

Detailed Description:

Although studies have suggested that plaque morphology and composition are important determinants of plaque stability, our understanding on plaque tissue components is mainly from histological studies until recent development in MRI technique. A low level of HDL is associated with higher risk of cardiovascular events and increased amount of lipid content in the carotid plaques. Treatment with LDL-lowering plus HDL-raising compared with LDL-lowering alone more effectively protects against atherosclerosis progression. It is widely believed that HDL or its apolipoproteins mediate the removal of excess free cholesterol from peripheral cells and the cholesterol is delivered via either LDL or HDL to the liver for excretion into the bile. However, it has not been tested and approved in human atherosclerotic condition in vivo. The NIH/Abbott-funded multi-center AIM-HIGH trial is designed to compare the clinical efficacy of LDL-lowering alone with statin versus LDL-lowering plus HDL-raising with statin plus nicotinic acid combination therapy in patients with established vascular disease and high triglycerides and low HDL.

We propose to conduct a carotid MRI sub-study in 220 subjects enrolled in AIM-HIGH to investigate the important vascular biological mechanisms of HDL-raising therapy. Image collection will occur at 3 timepoints. The hypotheses and specific aims are:

  • (1) To test the primary hypothesis that compared with LDL-lowering alone, intensive LDL-lowering plus HDL-raising therapy decreases the mean plaque lipid composition in carotid arteries assessed by MRI.
  • (2) To test the hypothesis that compared with LDL-lowering alone, intensive LDL-lowering plus HDL-raising therapy decreases the plaque burden including volume and wall thickness.
  • (3) To test the hypothesis that increased plaque lipid composition or vessel wall thickness by MRI is associated with increased risk of cardiovascular events.
  • (4)To test a hypothesis that LDL-lowering plus HDL-raising, compared to LDL-lowering alone, will promote more rapid plaque lipid depletion. And determine the time-course of atherosclerotic plaque lipid depletion during lipid therapy.
  • (5) To examine the association of clinical risk factors, lipids, lipoprotein heterogeneity, inflammatory markers and carotid plaque characteristics.

This MRI sub-study offers a unique opportunity to investigate the effectiveness of LDL-lowering plus HDL-raising therapy on human atherosclerotic plaque in vivo, to examine the association of plaque characteristics both lipid composition and volume assessed by MRI and cardiovascular outcome, and to gain novel insights in our understanding of atherosclerotic plaque pathology and the mechanisms of intensive lipid management in preventing cardiovascular events.

  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)
  • Medically able to undergo MRI procedure
  • Willing to provide informed consent for participation in this substudy

Exclusion Criteria:

  • Uses pacemaker or has metallic implants
  • History of bilateral carotid endarterectomy
  • Glomerular filtration rate less than 60 mL/min/1.73 m^2
  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: NCT01178320

Locations
United States, Arizona
Cardiovascular Consultants
Phoenix, Arizona, United States, 85032
United States, California
Long Beach VA Medical Center
Long Beach, California, United States, 90822
University of Southern California
Los Angeles, California, United States, 90033
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
Kelsey Research Foundation
Houston, Texas, United States, 77030
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
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Xue-Qiao Zhao, MD University of Washington
  More Information

No publications provided

Responsible Party: Xue-Qiao Zhao, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01178320     History of Changes
Other Study ID Numbers: 627, R01HL088214
Study First Received: August 5, 2010
Last Updated: May 19, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Magnetic Resonance Imaging
Atherosclerotic Plaque
Lipid Lowering Therapy

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Diseases
Niacin
Simvastatin
Nicotinic Acids
Niacinamide
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014