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Protocol Details

Randomized Trial of Imaging Versus Risk Factor Based Therapy for Plaque Regression

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-CC-0214

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 55
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Atherosclerosis;
Cardiovascular Disease;
Cardiac MRI;
Cardiac CT

Recruitment Keyword(s)

Atherosclerosis;
Cholesterol;
Cardiovascular Disease

Condition(s)

Atherosclerosis;
Hypercholesterolemia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: LDL. Cholesterol (Statin Drugs)
Drug: HMG-CoA Reductase Inhibitors

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

A. Men and Women greater than or equal to 55 years of age

B. Candidates for lipid lowering therapy under NCEP ATP III guidelines without contraindication to statin therapy

C. Willing to modify therapy to enroll in the study

D. Willing to travel to the NIH for follow-up visits.

E. Able to understand and sign informed consent

F. Lab Eligibility parameters:

- eGFR > 45 mL/min/m2

- For age > 60 test GFR within 1 week prior to contrast; For age less than or equal to 60 test within 4 weeks

INCLUSION CRITERIA FOR THE PET SUBSTUDY:

Participants who are not participating in the CT Reproducibility study are eligible.

INCLUSION CRITERIA FOR THE REPRODUCIBILITY SUBSTUDY:

Patients will be selected who had a one RR interval initial CT scan with less that 10.5 mSv estimated radiation dosage and who will not be participating in the PET Substudy.

EXCLUSION CRITERIA:

A. Ineligibility for MR imaging due to:

- Previous pacemaker implantation

- Automatic implantable cardioverter-defibrillator (AICD)

- Metal implants or other ferromagnetic devices, or

- Foreign material

B. Claustrophobia

C. Contra-indication or allergy to statin medications.

D. Current statin therapy at or above the maximum dosage permitted per study protocol (section 1.3,above).

E. Use of fibrates, ezetimibe, niacin, or bile acid binding agents within 6 months of screening visit.

F. Pregnancy and nursing.

G. Liver failure defined clinically and by laboratory data.

H. Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial.

I. Any other conditions that precludes safety for MRI and/or CT imaging per the researcher s evaluation.

EXCLUSION FOR PARTICIPATION FOR GADOLINUIM CONTRAST. PARTICIPANTS MAY STILL UNDERGO ALL OTHER STUDY EVALUATIONS.

(Inclusive of the above exclusion criteria):

1. Allergy to gadolinium for scans using contrast; will be eligible for non-contrast scans.

2. Acute renal failure, renal transplant, dialysis and renal failure (eGFR < 45 mL/min/m2 and/or clinically diagnosed).

3. Individuals with a history of liver transplant or severe liver disease.< TAB>

4. Individuals with hemoglobinopathies or severe asthma.

EXCLUSION FOR PARTICIPATION FOR IODINATED CONTRAST. PARTICIPANTS MAY STILL UNDERGO ALL OTHER SUDY EVALUATIONS.

Prior hypersensitivity reaction to iodinated contrast injection, renal dysfunction (defined as eGFR < 45 mL/min/ m2) or a current clinical diagnosis of renal failure.

EXCLUSION CRITERIA FOR THE PET SUBSTUDY:

Patients who are unable or unwilling to comply with the physical activity restrictions or fast for 12 hours prior to FDG PET scanning will be excluded. Due to the need for dietary manipulation and the maintenance of strict glycemic control we will exclude diabetic patients from our initial study sample. Blood glucose measurements before injection must be within normal limits, less than 200 mg/dL (11 mmol/L).

EXCLUSION CRITERIA FOR THE REPRODUCIBILITY

Patients who did not have a one RR interval initial CT scan. Patients who will participate in the PET Substudy.


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Citations:

Sibley C, Blumenthal RS, Merz CN, Mosca L. Limitations of current cardiovascular disease risk assessment strategies in women. J Womens Health (Larchmt). 2006 Jan-Feb; 15(1):54-6.

Wasserman BA, Sharrett AR, Lai S, Gomes AS, Cushman M, Folsom AR, Bild DE, Kronmal RA, Sinha S, Bluemke DA. Risk factor associations with the presence of a lipid core in carotid plaque of asymptomatic individuals using high-resolution MRI: the multi-ethnic study of atherosclerosis (MESA). Stroke. 2008 Feb;39(2):329-35. Epub 2008 Jan 3.

Wasserman BA, Smith WI, Trout HH 3rd, Cannon RO 3rd, Balaban RS, Arai AE. Carotid artery atherosclerosis: in vivo morphologic characterization with gadolinium-enhanced double-oblique MR imaging initial results. Radiology. 2002 May;223(2):566-73.

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Contacts:

Principal Investigator

Referral Contact

For more information:

David A. Bluemke, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C355
10 CENTER DR
BETHESDA MD 20814
(301) 402-1854
bluemked@mail.nih.gov

Marissa B. Mallek
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C351
10 Center Drive
Bethesda, Maryland 20892
(301) 496-7700
marissa.mallek@nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01212900

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