Magnetic Resonance Imaging of the Coronary Vessel Wall

NCT ID: NCT00456950

Last Updated: 2009-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-10-31

Brief Summary

Despite advances in prevention and treatment, clinical manifestations of atherosclerosis (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western world. The occurrence of acute ischemic syndromes, including unstable angina and myocardial infarction, is highly associated with atherosclerotic plaque morphology.

Magnetic resonance (MR) imaging is able to noninvasively depict the lumen of coronary arteries without the need for ionizing radiation. In addition, MR imaging is able to generate soft-tissue contrast unlike any other imaging modality. It has been shown in the aorta and carotid artery that MR imaging is able to identify different atherosclerotic plaque components in vivo. Similar MR imaging techniques are becoming available to visualize the coronary arterial wall and preliminary studies have shown the feasibility of MR coronary vessel wall imaging in humans.

The overall aim of the current study is to identify in vivo MR coronary vessel wall and plaque features that are associated with acute coronary syndromes. This study is divided into 2 substudies:

1. Detection of atherosclerosis in the coronary vessel wall with contrast-enhanced MR imaging in patients with coronary artery disease and age-matched healthy volunteers.

2. Characterization of coronary vessel wall plaque morphology in patients with stable and unstable angina: validation of MRI with the current standard of reference intravascular ultrasound (IVUS).

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• patients with (un)stable angina or non-ST-elevated myocardial infarction
• patients are scheduled for, or recently had X-ray coronary angiography
• healthy volunteers, no clinical history of coronary artery disease(control group for substudy 1)
• patients with non-ischemic heart disease, scheduled for X-ray coronary angiography (control group for substudy 2)
• informed consent

Exclusion Criteria

• severe arrhythmia
• hemodynamic unstable patients
• contra-indications for MRI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Radiology, Maastricht University Hospital

Principal Investigators

Tim Leiner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital

Locations

Maastricht University Hospital

Maastricht, , Netherlands

Countries

Netherlands

References

Gerretsen SC, Kooi ME, Kessels AG, Schalla S, Katoh M, van der Geest RJ, Manning WJ, Waltenberger J, van Engelshoven JM, Botnar RM, Leiner T. Visualization of coronary wall atherosclerosis in asymptomatic subjects and patients with coronary artery disease using magnetic resonance imaging. PLoS One. 2010 Sep 29;5(9):e12998. doi: 10.1371/journal.pone.0012998.

Reference Type: DERIVED

PMID: 20927368 (View on PubMed)

Other Identifiers

MEC 04-272

Identifier Type: -

Identifier Source: org_study_id