Gadofosveset Trisodium for Heart Imaging Studies

Completed

Conditions studied: Obstructive Coronary Artery Disease, Coronary Arteriosclerosis, Coronary Artery Disease (CAD)

In brief

Background: \- Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast agent is injected into a vein. Researchers are interested in finding contrast agents that can help show problems with the blood vessels around the heart. They want to test an agent called Gadofosveset Trisodium to see how it works in MRI scans. Objectives: \- To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design: * Participants will be screened with a physical exam and medical history. They will provide blood samples before the scanning sessions. * Participants will have an MRI scan after the screening visit. They will have a dose of the contrast scan before the study. * Participants will return for one additional MRI scan within 1 to 2 months of each scan. Different doses of the contrast agent will be used for each scan. * An additional blood sample will be collected within 1 week of the second MRI scan.

Key facts

Study ID

NCT01853592

Run by

National Institutes of Health Clinical Center (CC)

People needed

30

Starts

2013-03-08

Expected to finish

2016-12-13

Last updated by the study team

2018-09-10

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Individuals will be excluded from the study if they have:
• A. Contra-indications to undergoing a MRA
• Please review Radiology MRI section MRI safety questionnaire.
• B. MRI with contrast within the last 6 months (self-reported) outside of our protocol.
• C. Contra indications to receiving gadolinium-based contrast agent (specified here and on MRI safety questionnaire):
• Allergy to gadolinium-based contrast
• Labs:
• i. Kidney and liver function above the upper limits of normal
• ii. eGFR < 60ml/min/1.73m(2)
• iii. Pregnancy test: positive
• c. Acute renal failure, renal transplantation, curent dialysis treatment or hepatorenal syndrome
• d. History of liver transplantation or severe liver disease
• e. Severe Asthma
• f. Hemoglobinopathies
• g. History of multiple myeloma
• h. History of significant allergic reaction to gadolinium-based contrast agents
• i. Evaluated to be at increased risk for Nephrogenic Systemic Fibrosis (NSF).
• D. Current written (or self-reported) record of:
• atrial fibrillation
• cardiac surgery
• cancer treatment
• other comorbid conditions that otherwise indicates the participant has renal function that may deteriorate between study procedures due to the participant s underlying medical condition or that would not allow the study subject to complete the protocol.
• E. Current written (or self-reported) record of active:
• Clinically diagnosed angina, heart failure, and/or clinically significant electrical conduction abnormality in the heart.
• Pregnancy or lactation

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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