A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

McGill University Health Centre/Research Institute of the McGill University Health Centre1 site in 1 country2,130 target enrollmentDecember 12, 2019

ConditionsCoronary Artery Disease Myocarditis Infiltrative Cardiomyopathy Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Aortic Valve Stenosis Aortic Valve Regurgitation Pericardial Effusion Congenital Heart Disease Vascular Anomaly

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment: 2130
Locations: 1
Primary Endpoint: Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to identify and assess new CMR techniques that can improve current CMR protocols.

Detailed Description

The aim of this study is to develop a comprehensive 10-minute protocol based on function and myocardial tissue characterization without the need for contrast injection, which can be standardized for 70% of cardiac patients. To test this 10-minute CMR protocol for its ability to significantly improve diagnostic decision-making and to reduce cost. To test its clinical feasibility, performance and cost-effectiveness in different populations including: Non-ischemic cardiomyopathies (-)OS-CMR and Ischemic Heart Disease and CAD (+)OS-CMR

Registry

clinicaltrials.gov

Start Date

December 12, 2019

End Date

January 31, 2025

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Responsible Party

Principal Investigator

Matthias Friedrich

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

•Age: \> 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system

Exclusion Criteria

•General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.Regular nicotine consumption during the last 6 months
•Inclusion Criteria:
•Age: \>18 y, Informed consent, Clinically indicated CMR exam
•Exclusion Criteria:
•General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.
•Regular nicotine consumption during the last 6 months

Outcomes

Primary Outcomes

Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease

Time Frame: 2019-2025

(Patients with suspected coronary artery disease:) Agreement of the main finding regarding the presence of a coronary territory at risk for inducible myocardial ischemia myocardial derived from OS-CMR, compared with standard first-pass perfusion CMR, using the coronary angiography report as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR first pass perfusion scan will be used as the standard of truth.

Primary diagnosis comparison between SMART CMR and standard CMR

Time Frame: 2019-2025

(All patients) Agreement of the suggested primary diagnosis derived from SMART CMR, compared with the diagnosis established from standard CMR protocols, using the final clinical diagnosis as established by the treating physician, as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR protocol will be used as the standard of truth.