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

NCT00984776 | Completed

• 1 other identifier: MEC 06-1-036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Stable Angina; Unstable Angina

Keywords

coronary artery; MRI; vessel wall imaging

Outcome Measures

Primary Outcomes (1)

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

  1 week

Secondary Outcomes (1)

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

  1 day

Interventions

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

Also known as: Vasovist, MS-325

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Bayer: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 22782568 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina, Unstable

Interventions

gadofosveset trisodium

Condition Hierarchy (Ancestors)

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

Study Officials

• Tim Leiner, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 25, 2009
• Study Start: March 1, 2007
• Primary Completion: February 1, 2009
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

NL (1)