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NCT01212900 · ClinicalTrials.gov registry record · Phase 4
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
A Phase 4 study of Atherosclerosis and Hypercholesterolemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 4
- Development phase
- 230
- Enrollment target
- 1
- Study location
NCT01212900 is a Phase 4 study of Atherosclerosis and Hypercholesterolemia that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 230 participants, below the 1,062-participant average among 69 other Atherosclerosis trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01212900, a Phase 4 study of Atherosclerosis and Hypercholesterolemia, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 230 participants
- Enrollment target
- 1
- Study location
Study 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 vi
Conditions Studied
Interventions
- DRUG Statins, HMG CoA
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2010-09-30 |
| Est. Completion | 2017-02-22 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01212900
The ClinicalTrials.gov registry entry for NCT01212900 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,062-participant average among 69 other Atherosclerosis trials with a reported enrollment target (78% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Atherosclerosis appearing as the primary indexed condition, and to 1 intervention - of which Statins, HMG CoA is the first listed.
NCT01212900 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01212900 about?
NCT01212900 is a clinical study titled "Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression". 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 w...
What is the current status of trial NCT01212900?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 230 participants. The study started on 2010-09-30. Estimated completion is 2017-02-22.
What conditions does trial NCT01212900 study?
This clinical trial studies the following conditions: Atherosclerosis, Hypercholesterolemia.
What interventions are being tested in trial NCT01212900?
The interventions under investigation include: Statins, HMG CoA (DRUG).
Who is sponsoring clinical trial NCT01212900?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01212900 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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