Magnetic Resonance Imaging of the Coronary Vessel Wall

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00456950
First received: April 4, 2007
Last updated: September 23, 2009
Last verified: September 2009
  Purpose

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).

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Vulnerable Plaque With Coronary Vessel Wall Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Enrollment: 75
Study Start Date: October 2005
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456950

Locations
Netherlands
Maastricht University Hospital
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Tim Leiner, MD, PhD Maastricht University Hospital
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: T. Leiner, M.D., PhD, Dept. of Radiology, Maastricht University Hospital
ClinicalTrials.gov Identifier: NCT00456950     History of Changes
Other Study ID Numbers: MEC 04-272
Study First Received: April 4, 2007
Last Updated: September 23, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
coronary atherosclerosis
magnetic resonance imaging
vulnerable plaque

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014