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

NCT ID: NCT00984776

Last Updated: 2009-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Stable Angina Unstable Angina

Study Design

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Primary Study Purpose

DIAGNOSTIC

Interventions

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Contrast enhanced MRI with Gadofosveset

0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheter

Intervention Type OTHER

Other Intervention Names

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Vasovist MS-325

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University Medical Center

Principal Investigators

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Tim Leiner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 22782568 (View on PubMed)

Other Identifiers

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MEC 06-1-036

Identifier Type: -

Identifier Source: org_study_id

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