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

Coronary Artery Disease Clinical Trial

— T9M  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984776
• Other study ID #: MEC 06-1-036
• Status: Completed
• Phase: N/A
• First received: September 23, 2009
• Last updated: September 24, 2009
• Start date: March 2007

Study information

• Verified date: September 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina
• Unstable Angina

Intervention

Other:
• Contrast enhanced MRI with Gadofosveset
0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheter

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of MRI: comparison with IVUS. Can plaque be detected?		1 week	No
Secondary	uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall?		1 day	No