Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging (T9M)
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|ClinicalTrials.gov Identifier: NCT00984776|
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : September 25, 2009
MRI has the ability to visualize the arterial vessel wall. Wall thickening and atherosclerotic plaque components can be visualized in the carotid arteries and the aorta. Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall. The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial infarction.
The goal of this study was to validate MRI of the coronary vessel wall by comparing it to intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall and to look at the uptake of the albumin-binding contrast agent gadofosveset in atherosclerotic plaques. The main hypothesis is that due to the albumin binding characteristics, uptake of the contrast agent will take place in the more vulnerable plaques compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and intravascular ultrasound, two techniques currently considered as the standard of reference for imaging of the coronary arteries and vessel wall.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Stable Angina Unstable Angina||Other: Contrast enhanced MRI with Gadofosveset||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Official Title:||Detection of Vulnerable Plaque With Coronary Vessel Wall MRI: Contrast Enhanced MRI With Gadofosveset MS-325.|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||February 2009|
- Other: Contrast enhanced MRI with Gadofosveset
0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheterOther Names:
- Validation of MRI: comparison with IVUS. Can plaque be detected? [ Time Frame: 1 week ]
- uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall? [ Time Frame: 1 day ]
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): NCT00984776
|Maastricht University Medical Center|
|Maastricht, Netherlands, 6229 HX|
|Principal Investigator:||Tim Leiner, MD, PhD||Maastricht University Medical Center|