Magnetic Resonance Imaging of the Coronary Vessel Wall

September 23, 2009 updated by: Maastricht University Medical Center

Detection of Vulnerable Plaque With Coronary Vessel Wall Magnetic Resonance Imaging

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Tim Leiner, MD, PhD, Maastricht University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Estimate)

September 24, 2009

Last Update Submitted That Met QC Criteria

September 23, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 04-272

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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