Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The overall aim of this proposal is to compare the effectiveness of an image guided approach to lipid lowering to standard therapy guided by clinical risk factors and blood lipid levels. Men and women over age 55 who are candidates for statin therapy will be randomized to usual cholesterol lowering care, or to care guided by MRI images of the carotid arteries. Participants randomized to the second, imaging guided, group will be assigned to LDL cholesterol targets according to the degree of atherosclerosis seen by MRI. The study endpoints will be the total degree of plaque regression seen, the dosage of statin drugs required to achieve that reduction, and the rate of cardiovascular events.

FDG-PET is hypothesized to enable visualization of anti-inflammatory effects of statins that most likely occur before anatomic regression of the plaques can be demonstrated on MRI. A pilot substudy is to be conducted to explore this relationship. A subgroup of patients participating in the main study will be asked to participate in FDG PET imaging. The purpose of this pilot study is to determine if FDG avid lesions undergo a greater degree of morphologic regression with therapy controlling for the reduction in LDL cholesterol and the dosage of statins required to achieve that target.

Although contrast-enhanced coronary CT angiography (CTA) with multidetector computed tomography (MDCT) has been used extensively to characterize coronary artery plaque composition, there is little data regarding its reproducibility. A recent study demonstrated excellent reproducibility for this technique but this study was performed using the older 64 detector row CT scanners2. A pilot substudy will be conducted to study the reproducibility of coronary CT angiography using the newer generation of 320 detector row CT scanners. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01212900
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 4
Start date September 30, 2010
Completion date February 22, 2017

See also
  Status Clinical Trial Phase
Recruiting NCT05052918 - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Completed NCT05906797 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis. N/A
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Suspended NCT02932176 - Machine Learning for Handheld Vascular Studies
Recruiting NCT05158257 - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Recruiting NCT06230406 - T-Mem GEne in Atherosclerosis
Completed NCT03654313 - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT02894931 - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity N/A
Completed NCT02998918 - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A
Recruiting NCT02265250 - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed NCT02224339 - New Technologies to Determine Carotid Plaque Vulnerability
Completed NCT03393377 - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination N/A
Completed NCT02268513 - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Completed NCT02377310 - Pd/Pa vs iFRâ„¢ in an Unselected Population Referred for Invasive Angiography N/A
Not yet recruiting NCT01923012 - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis Phase 2
Completed NCT02116829 - Is There Room for Butter in a Healthy Diet? N/A