Clinical trial NCT00456950: Magnetic Resonance Imaging of the Coronary Vessel Wall
Official title: Detection of Vulnerable Plaque With Coronary Vessel Wall Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary atherosclerosis
magnetic resonance imaging
vulnerable plaque
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients with (un)stable angina or non-st-elevated myocardial infarction: sample from dept. of cardiology
* healthy volunteers: community sample

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).


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
Study officials:
affiliation: Maastricht University Hospital
name: Tim Leiner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.