Imaging of Totally Blocked Arteries

NCT00459446 | Completed Phase 1

• 2 other identifiers: 07012807-H-0128
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test how well a new contrast agent (dye) used in magnetic resonance imaging (MRI) can help visualize totally blocked arteries that normally supply blood to the neck, arms or legs. Currently used agents work well in visualizing normal or partly blocked arteries (arteries that have some blood flowing through them), but only poorly in totally blocked arteries. This study will see if a contrast agent called gadofosveset can better brighten images of completely blocked arteries. Gadofosveset is approved in Europe for use in MRI scans, but is still considered experimental in the United States. People 18 years of age or older with known or suspected total blockage of an artery to the neck, arm or leg may be eligible for this study. Participants undergo MRI scanning with gadofosveset contrast dye. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the subject lies on a table that can slide in and out of the tubular scanner, wearing earplugs to muffle loud noises that occur during the scanning process. The procedure lasts about 1.5 to 2 hours, during which the subject may be asked to hold his or her breath several times for as long as 5 to 20 seconds. During the procedure, gadofosveset is injected and several kinds of MRI pictures are taken to understand better how the new agent works. Subjects may be asked to undergo a second scan using conventional MRI contrast dye

Conditions

Atherosclerosis; Peripheral Artery Disease; Intermittent Claudication; Chronic Total Aterial Occlusion

Keywords

Magnetic Resonance Imaging; Gadolinium Contrast; Gadofosveset; Atherosclerosis; Chronic Total Arterial Occlusions; Cardiovascular Disease; Blocked Arteries; Peripheral Artery Disease; PAD; Intermittent Claudication; Chronic Total Arterial Occlusion

Outcome Measures

Primary Outcomes (1)

• Conspicuity of occluded arteries after contrast exposure.

Interventions

MS-325 Injection (Gadofosveset Trisodium) DRUG

Eligibility Criteria

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

You may qualify if:

• Subjects with known cardiovascular disease will be eligible for participation in this protocol. The subject is eligible under the following conditions:
• Subject's age is greater than 18 years of age.
• Known occlusion of iliac, femoral, or brachiocephalic arteries.

You may not qualify if:

• Subjects with absolute contraindications to MRI scanning will be excluded. These contraindications include subjects with the following devices:
• Implanted cardiac pacemaker or defibrillator.
• Central nervous system aneurysm clips.
• Implanted neural stimulator.
• Cochlear implant.
• Ocular foreign body (e.g. metal shavings).
• Insulin pump.
• Metal shrapnel or bullet.
• Furthermore, certain subject groups will be excluded because of the administration of MRI contrast agents. The weight limit is related to availability of investigational contrast agents. Because of recent concerns about Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy after gadobenate exposure in patients with end-stage renal disease, renal excretory function will be determined and patients with severe renal excretory dysfunction are excluded from this research protocol.
• Pregnant women (subjects who are uncertain as to whether they are pregnant will be required to have a quantitative serum pregnancy test within 72 hours) or lactating women.
• Subjects who have experienced an allergic reaction to gadolinium-based contrast agents.
• Subjects with hemoglobinopathies.
• Weight greater than 120 kg.
• Subjects with renal disease (eGFR less than 30 ml/min/1.73m(2), or receiving renal replacement therapy).
• The creatinine clearance will be estimated in all subjects as an estimated glomerular filtration rate (eGFR) using the abbreviated MDRD Formula.

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)

• Farooki A, Narra V, Brown J. Gadofosveset (EPIX/Schering). Curr Opin Investig Drugs. 2004 Sep;5(9):967-76.

  PMID: 15503653 BACKGROUND

• Goyen M, Edelman M, Perreault P, O'Riordan E, Bertoni H, Taylor J, Siragusa D, Sharafuddin M, Mohler ER 3rd, Breger R, Yucel EK, Shamsi K, Weisskoff RM. MR angiography of aortoiliac occlusive disease: a phase III study of the safety and effectiveness of the blood-pool contrast agent MS-325. Radiology. 2005 Sep;236(3):825-33. doi: 10.1148/radiol.2363040577. Epub 2005 Jul 14.

  PMID: 16020554 BACKGROUND

• Bluemke DA, Stillman AE, Bis KG, Grist TM, Baum RA, D'Agostino R, Malden ES, Pierro JA, Yucel EK. Carotid MR angiography: phase II study of safety and efficacy for MS-325. Radiology. 2001 Apr;219(1):114-22. doi: 10.1148/radiology.219.1.r01ap42114.

  PMID: 11274545 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Peripheral Arterial Disease; Intermittent Claudication; Cardiovascular Diseases

Interventions

gadofosveset trisodium

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 11, 2007
• First Posted: April 12, 2007
• Study Start: April 5, 2007
• Primary Completion: November 25, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-11-25

Locations

US (1)