Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging (T9M)
Primary Purpose
Coronary Artery Disease, Stable Angina, Unstable Angina
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Contrast enhanced MRI with Gadofosveset
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery, MRI, vessel wall imaging
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Center
Outcomes
Primary Outcome Measures
Validation of MRI: comparison with IVUS. Can plaque be detected?
Secondary Outcome Measures
uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall?
Full Information
NCT ID
NCT00984776
First Posted
September 23, 2009
Last Updated
September 24, 2009
Sponsor
Maastricht University Medical Center
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00984776
Brief Title
Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging
Acronym
T9M
Official Title
Detection of Vulnerable Plaque With Coronary Vessel Wall MRI: Contrast Enhanced MRI With Gadofosveset MS-325.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Bayer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Stable Angina, Unstable Angina
Keywords
coronary artery, MRI, vessel wall imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Contrast enhanced MRI with Gadofosveset
Other Intervention Name(s)
Vasovist, MS-325
Intervention Description
0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheter
Primary Outcome Measure Information:
Title
Validation of MRI: comparison with IVUS. Can plaque be detected?
Time Frame
1 week
Secondary Outcome Measure Information:
Title
uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall?
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Leiner, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22782568
Citation
Gerretsen S, Kessels AG, Nelemans PJ, Dijkstra J, Reiber JH, van der Geest RJ, Katoh M, Waltenberger J, van Engelshoven JM, Botnar RM, Kooi ME, Leiner T. Detection of coronary plaques using MR coronary vessel wall imaging: validation of findings with intravascular ultrasound. Eur Radiol. 2013 Jan;23(1):115-24. doi: 10.1007/s00330-012-2576-1. Epub 2012 Jul 11.
Results Reference
derived
Learn more about this trial
Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging
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