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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
Maastricht University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring coronary artery, MRI, vessel wall imaging

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 23, 2009
Last Updated
September 24, 2009
Sponsor
Maastricht University Medical Center
Collaborators
Bayer
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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

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

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