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Completed

NCT Number: NCT00984776

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Unstable Angina Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contrast enhanced MRI with Gadofosveset

Other

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

Other names: Vasovist, MS-325

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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Bayer

Registry information

Official study title

Detection of Vulnerable Plaque With Coronary Vessel Wall MRI: Contrast Enhanced MRI With Gadofosveset MS-325.

Acronym: T9M

Important dates

Study start
2007
Primary completion
2009
First posted
Sep 25, 2009
Registry last updated
Sep 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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