A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Myocarditis; Dilated Cardiomyopathy; Congenital Heart Disease; Hypertrophic Cardiomyopathy; Pericardial Effusion; Aortic Valve Regurgitation; Vascular Anomaly; Infiltrative Cardiomyopathy

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

• Study Type: Observational
• Enrollment (Estimated): 2130

Contacts and Locations

• Study Contact: Name: Elizabeth Konidis; Phone Number: 37305 514-934-1934; Email: elisavet.konidis@muhc.mcgill.ca
• Study Contact Backup: Name: Adonis Rodaros; Phone Number: 37305 514-934-1934; Email: adonis.rodaros@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Center
      • Contact: Elizabeth Konidis; Phone Number: 37305 514-934-1934; Email: elisavet.konidis@muhc.mcgill.ca
      • Contact: Matthias G Friedrich, MD; Phone Number: 62800 514-934-1934; Email: matthias.friedrich@mcgill.ca
      • Sub-Investigator: Katerina Eyre, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of patients with suspected cardiovascular disease who are scheduled for a clinical CMR scan as part of a routine clinical work-up.

Patients will be stratified according to the clinical indication for CMR and their suspected or known clinical diagnosis.

Description

Healthy Volunteers

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

Patients

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Volunteers; Age: >18 y, No known current or pre-existing medical conditions that would affect the cardiovascular or respiratory system.
Patients; Age: > 18y, Clinically indicated CMR exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary diagnosis comparison between SMART CMR and standard CMR	(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.	2019-2025
Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease	(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.	2019-2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SMART CMR scan completion percentage	Proportion of SMART CMR scans that could be completed according to the protocol	2019-2025
OS-CMR scan completion percentage	Proportion of OS-CMR scans that could be completed according to the protocol	2019-2025
Adverse event monitoring during SMART CMR sequences	Number and proportion of reported adverse events effects during SMART CMR	2019-2025
Adverse event monitoring during OS-CMR sequence	Number and proportion of reported adverse events during OS-CMR	2019-2025
SMART CMR sequence times vs standard protocol sequence times	Observed scan time for SMART CMR compared with the standard CMR protocol	2019-2025
OS-CMR sequence times vs standard protocol sequence times	Observed scan time for for OS-CMR during breathing maneuvers compared with the standard CMR first-pass perfusion protocol	2019-2025
Cost comparison of SMART CMR vs standard CMR protocol	Total estimated cost of SMART CMR compared with the standard CMR protocol	2019-2025
Cost comparison of OS-CMR vs standard CMR protocol	Total cost of OS-CMR with breathing maneuvers (based on scan time) vs the standard CMR first-pass perfusion protocol (calculated from the scan time plus any other material such as contrast agents or pharmacological vasodilators)	2019-2025
Septal myocardial T1 vs standard myocardial T1	Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping	2019-2025
Septal myocardial T2 vs standard myocardial T2	Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping	2019-2025
Quantitative parameter comparison between SMART CMR and CINE images	Quantitative parameters relevant to the diagnosis (see Appendix: CanSCMR Recommendations for reporting CMR) measured in SMART CMR images, compared with results from standard CMR cine images	2019-2025
Strain measurements vs standard cine image measurements	Longitudinal and circumferential strain measurements measured in SMART CMR images, compared with results from standard CMR cine images	2019-2025
SMART-CMR post-stenotic peak flow vs standard CMR flow images	Post-stenotic peak flow velocity in patients with suspected valvular disease measured in SMART CMR images, compared with results from standard CMR flow images	2019-2025
Intra- and inter-reader reproducibility	Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.	2019-2025
Inter- and intra-scanner variability	Inter- and intra- scanner variability as assessed by ICC and kappa	2019-2025

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Matthias G Friedrich, MD, Research Institute of the McGill University Health Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Cardiovascular Abnormalities; Cardiomegaly; Laminopathies; Aortic Stenosis, Subvalvular; Heart Diseases; Coronary Artery Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Myocarditis; Cardiomyopathies; Cardiomyopathy, Dilated; Heart Defects, Congenital; Cardiomyopathy, Hypertrophic; Pericardial Effusion; Vascular Malformations
• Other Study ID Numbers: 2020-6128

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No