Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging (T9M)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00984776
First received: September 23, 2009
Last updated: September 24, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Stable Angina
Unstable Angina
Other: Contrast enhanced MRI with Gadofosveset

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Detection of Vulnerable Plaque With Coronary Vessel Wall MRI: Contrast Enhanced MRI With Gadofosveset MS-325.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Validation of MRI: comparison with IVUS. Can plaque be detected? [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall? [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2007
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Names:
    • Vasovist
    • MS-325
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00984776

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Bayer
Investigators
Principal Investigator: Tim Leiner, MD, PhD Maastricht University Medical Center
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: T. Leiner, M.D., PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00984776     History of Changes
Other Study ID Numbers: MEC 06-1-036
Study First Received: September 23, 2009
Last Updated: September 24, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
coronary artery
MRI
vessel wall imaging

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina, Stable
Angina, Unstable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Gadofosveset trisodium
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014