CClinicalTrials.gg
CompletedNCT00984776T9MUpdated Sep 25, 2009

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

An interventional study of Contrast enhanced MRI with Gadofosveset in Coronary Artery Disease, Stable Angina and Unstable Angina, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-09-25.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
  • Stable Angina
  • Unstable Angina

Keywords

  • coronary artery
  • MRI
  • vessel wall imaging
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 20 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • arrhythmia
  • hemodynamic unstable patients
  • contra-indications for (contrast-enhanced) MRI
  • age \< 18 yrs or > 90 yrs
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Enrollment
20 participants (actual)

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

    Also known as: Vasovist, MS-325

06

What researchers measure

Primary outcomes

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

    Time frame: 1 week

Secondary outcomes

  1. uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall?

    Time frame: 1 day

07

Study locations

1 site
  • Maastricht University Medical Center
    Maastricht, 6229 HX, Netherlands
08

References and documents

Publications

  • 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. PubMed 22782568 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00984776
Lead sponsor
Maastricht University Medical Center
Collaborators
Bayer
First posted
Sep 25, 2009
Start date
Mar 2007
Primary completion
Feb 2009
Last update
Sep 25, 2009

Study contacts

Tim Leiner, MD, PhD
principal investigator · Maastricht University Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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