Skip to content

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

Detection of Vulnerable Plaque With Coronary Vessel Wall MRI: Contrast Enhanced MRI With Gadofosveset MS-325.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00984776
Acronym
T9M
Enrollment
20
Registered
2009-09-25
Start date
2007-03-31
Completion date
Unknown
Last updated
2009-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Stable Angina, Unstable Angina

Keywords

coronary artery, MRI, vessel wall imaging

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.

Interventions

OTHERContrast enhanced MRI with Gadofosveset

0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheter

Sponsors

Bayer
CollaboratorINDUSTRY
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Validation of MRI: comparison with IVUS. Can plaque be detected?1 week

Secondary

MeasureTime frame
uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall?1 day

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026