Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
Status:
Completed
Trial end date:
2017-02-22
Target enrollment:
Participant gender:
Summary
Background:
- Atherosclerosis (thickening of the artery walls caused by cholesterol and other deposits)
commonly occurs in the heart vessels and carotid (neck) arteries of adults. This is often
present in individuals with high cholesterol levels in their blood. These patients are
usually treated with cholesterol lowering medication ( statins ) along with modification of
diet and exercise. Researchers are interested in investigating new approaches including
magnetic resonance imaging (MRI) and computed tomography (CT) imaging studies to detect blood
vessel blockages that would not otherwise be detected by cholesterol levels and risk factors
for heart disease.
Objectives:
- To measure atherosclerosis in the heart vessels and carotid arteries using imaging tests
(computed tomography (CT) and magnetic resonance imaging (MRI)) before and after standard
treatment with cholesterol lowering medication ( statins )
Eligibility:
- Healthy individuals at least 55 years of age who are candidates for therapy to lower their
blood cholesterol levels.
Design:
- This study will involve one screening visit and seven study visits over a period of 2
years.
- Participants will be screened with a physical examination and medical history, as well
as blood samples and tests to ensure that it is safe for them to have CT and MRI scans.
Participants will provide information on current medications, dietary habits, smoking
status, alcohol and caffeine intake, and their level of physical activity.
- Participants will be divided into two groups. One group will receive standard doses of
medication to lower cholesterol according to current treatment guidelines, while the
other group will have MRI scans of the carotid arteries and a CT scan of the heart to
determine the best medication dose levels.
- Visits 3 to 5 will be scheduled 3, 6, and 9 months after visit 2. During these visits,
researchers will monitor for possible side effects and may change or adjust medications
and doses.
- At visit 6, participants will have an MRI scan of the carotid arteries, a physical
examination, and blood tests. Medications may be changed or adjusted.
- At visit 7, participants will have blood tests, and medications may be changed or
adjusted.
- At the final visit, participants will have MRI and CT scans of the carotid arteries and
heart, respectively, as well as a final physical examination and blood tests.
Phase:
Phase 4
Details
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI) National Institutes of Health Clinical Center (CC)