Ultrasound and Other Images of Artery Blockages

NCT01419574 | Terminated

• 2 other identifiers: 11022411-H-0224
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atherosclerosis

Keywords

Carotid Artery Plaque; Contrast Agents; Vasa Vasorum; MRI; Intraplaque Hemorrhage; Solid Tumor; Metastatic Solid Tumor

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1161/01.CIR.0000087480.94275.97.

  PMID: 14530185 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.106.628875. Epub 2007 Jan 22.

  PMID: 17242284 BACKGROUND

• 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. doi: 10.1016/j.jacc.2010.05.059.

  PMID: 21126642 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Carotid Stenosis; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vandana Sachdev, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 18, 2011
• Study Start: July 29, 2011
• Study Completion: April 27, 2016
• Last Updated: December 3, 2019

Record last verified: 2016-04-27

Locations

US (1)