Magnetic Resonance Imaging of the Coronary Vessel Wall | NCT00456950

Studies
Magnetic Resonance Imaging of the Coronary Vessel Wall

NCT00456950

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Sep 24, 2009Estimated

Enrollment

75Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Jun 2008Actual

Completion Date

Not provided

First Submitted Date

Apr 4, 2007

First Submission Date that Met QC Criteria

Apr 4, 2007

First Posted Date

Apr 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2009

Last Update Posted Date

Sep 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with (un)stable angina or non-st-elevated myocardial infarction: sample from dept. of cardiology
healthy volunteers: community sample

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Leiner, MD, PhD	Maastricht University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Hospital		Maastricht		6229 HX	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20927368	Derived	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.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases