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Protocol Details

Contrast-Enhanced Ultrasound Imaging of Carotid Plaque Neovascularization

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

11-H-0224

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 21
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Carotid Artery Plaque;
Contrast Agents;
Vasa Vasorum;
MRI;
Intraplaque Hemorrhage

Recruitment Keyword(s)

Solid Tumor;
Metastatic Solid Tumor

Condition(s)

Carotid Artery Plaque

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung and Blood Institute

Background:

- Treatments for partly blocked carotid arteries are determined by a person s symptoms and by tests that show how severe the blockage is. Studies show that the material that blocks an artery is more important in spotting future problems than how tight the blockage is. Researchers want to develop better imaging studies to find which blockages are more high-risk.

Objectives:

- To use imaging studies to look at high-risk carotid artery blockages.

Eligibility:

- Individuals at least 21 years of age whose ultrasound exams show a major carotid artery blockage.

Design:

- Participants will be screened with a medical history, physical exam, blood and urine tests, , an ultrasound scan and a magnetic resonance imaging (MRI) scan.

- Participants will have ultrasound and other scans to obtain pictures of the arteries. The scans will use drugs that may help study doctors get a better picture of the blood vessels and blockages.

- Participants will have followup phone calls yearly for 3 years. If a participant later has surgery to remove the blockage, the surgeon will save part of it for future study.

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Eligibility

INCLUSION CRITERIA:

Inclusion Criteria for Group A:

-Adult subjects age greater than or equal to 21 years

-Able to give written informed consent

-Prior clinical ultrasound exam showing a carotid stenosis of greater than or equal to 50 percent

Inclusion Criteria for Group B:

-Adult subjects age greater than or equal to 21 years

-Able to give written informed consent

-Prior clinical ultrasound exam showing a carotid stenosis suspected of causing symptoms and/or clinical recommendation to undergo carotid endarterectomy

EXCLUSION CRITERIA:

-Atrial fibrillation or other irregular rhythm that would preclude adequate image acquisition

-Subjects with a contraindication for the ultrasound contrast agent.

-Subjects with pacemakers, defibrillators, cerebral aneurysm clips, neural stimulators, ear implants or other clinical contra-indications for magnetic resonance scanning will be excluded from the MRI portion of the study.

-Subjects with an estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73 m(2) body surface area will be excluded from the contrast MRI portion of the study but will still undergo non-contrast imaging.

-The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to subjects with acute renal insufficiency: eGFR (ml/min/1.73 m(2)) equal to 175 times (serum creatinine)-1.154 times (age)-0.203 times 0.742 (if the subject is female) times 1.212 (if the subject is black).

-Pregnant or lactating women


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Citations:

Naghavi M, Libby P, Falk E, Casscells SW, Litovsky S, Rumberger J, Badimon JJ, Stefanadis C, Moreno P, Pasterkamp G, Fayad Z, Stone PH, Waxman S, Raggi P, Madjid M, Zarrabi A, Burke A, Yuan C, Fitzgerald PJ, Siscovick DS, de Korte CL, Aikawa M, Juhani Airaksinen KE, Assmann G, Becker CR, Chesebro JH, Farb A, Galis ZS, Jackson C, Jang IK, Koenig W, Lodder RA, March K, Demirovic J, Navab M, Priori SG, Rekhter MD, Bahr R, Grundy SM, Mehran R, Colombo A, Boerwinkle E, Ballantyne C, Insull W Jr, Schwartz RS, Vogel R, Serruys PW, Hansson GK, Faxon DP, Kaul S, Drexler H, Greenland P, Muller JE, Virmani R, Ridker PM, Zipes DP, Shah PK, Willerson JT. From vulnerable plaque to vulnerable patient: a call for new definitions and risk assessment strategies: Part I. Circulation. 2003 Oct 7;108(14):1664-72.

Lorenz MW, Markus HS, Bots ML, Rosvall M, Sitzer M. Prediction of clinical cardiovascular events with carotid intima-media thickness: a systematic review and meta-analysis. Circulation. 2007 Jan 30;115(4):459-67. Epub 2007 Jan 22.

Costanzo P, Perrone-Filardi P, Vassallo E, Paolillo S, Cesarano P, Brevetti G, Chiariello M. Does carotid intima-media thickness regression predict reduction of cardiovascular events? A meta-analysis of 41 randomized trials. J Am Coll Cardiol. 2010 Dec 7;56(24):2006-20.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Vandana Sachdev, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 5-1436
10 CENTER DR
BETHESDA MD 20814
(301) 496-3015
vs74y@nih.gov

Cynthia L. Brenneman, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 5-1436
10 Center Drive
Bethesda, Maryland 20892
(301) 451-3799
brennemc@nhlbi.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:

NCT01419574

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