Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Stable Angina; Unstable Angina

• Registration Number: NCT00984776
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2009-02
• Status Verified: 2009-09
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-24
• Last Update Submitted: 2009-09-24
• Study First Posted: 2009-09-25
• Last Update Posted: 2009-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• scheduled X-ray angiography for known coronary artery disease, valvular disease or chest pain with unknown origin
• age > 18 yrs and < 90 yrs
• Informed consent

Exclusion Criteria

• arrhythmia
• hemodynamic unstable patients
• contra-indications for (contrast-enhanced) MRI
• age < 18 yrs or > 90 yrs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of MRI: comparison with IVUS. Can plaque be detected?	1 week

Secondary Outcome Measures

Name	Time	Method
uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall?	1 day

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands