Gadofosveset Trisodium for Heart Imaging Studies
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|ClinicalTrials.gov Identifier: NCT01853592|
Recruitment Status : Completed
First Posted : May 15, 2013
Last Update Posted : February 26, 2018
- 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.
- To test the effectiveness of Gadofosveset Trisodium as a contrast agent in heart MRI scans.
- Healthy volunteers between 18 and 45 years of age.
- 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.
|Condition or disease|
|Obstructive Coronary Artery Disease Coronary Arteriosclerosis Coronary Artery Disease (CAD)|
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 Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||A Pilot Dosing Study for Gadofosveset Trisodium (Ablavar) for Coronary Magnetic Resonance Angiography (MRA)|
|Study Start Date :||March 8, 2013|
|Actual Primary Completion Date :||February 11, 2014|
|Actual Study Completion Date :||December 13, 2016|
- 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. [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853592
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||David A Bluemke, M.D.||National Institutes of Health Clinical Center (CC)|