Gadofosveset Trisodium for Heart Imaging Studies

Completed

• Conditions: Coronary Artery Disease (CAD); Coronary Arteriosclerosis; Obstructive Coronary Artery Disease

• Registration Number: NCT01853592
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

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.

Detailed Description

The purpose of this study is to determine if the diagnostic quality of contrast-enhanced coronary magnetic resonance angiography (MRA) is improved by using a higher versus a lower dose of a gadolinium-based contrast agent. We will compare two doses of an intravascular contrast agent (Gadofosveset, 0.03 and 0.06 mmol/kg) in this pilot dosing study. Healthy participants will be recruited who do not have a clinical indication for MR angiography but do have safety clearance for IV gadolinium contrast and MR scanning.

Subjects will be evaluated in order to determine if the signal to noise ratio (SNR) and contrast to noise ratio (CNR) of the coronary arteries is increased for the higher dose contrast agent. Parameters will be compared with paired t-testing for significance.

Study Timeline

• Study Start: 2013-03-08
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Primary Completion: 2014-02-11
• Status Verified: 2016-12-13
• Study Completion: 2016-12-13
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate 0.06 mmol/kg Gadofosveset trisodium compared to 0.03 mmol/kg Gadofosveset trisodium for the diagnostic quality of MRA of the coronary arteries, as measured by changes in signal to noise & contrast to noise ratios.	18 months

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States