A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Coronary Artery Disease Clinical Trial

Official title:

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04464655
• Other study ID #: 2020-6128
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Elizabeth Konidis
• Phone: 514-934-1934
• Email: elisavet.konidis[@]muhc.mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2130
• Est. completion date: January 31, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Regurgitation
• Aortic Valve Stenosis
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Congenital Heart Disease
• Coronary Artery Disease
• Dilated Cardiomyopathy
• Heart Defects, Congenital
• Heart Diseases
• Hypertrophic Cardiomyopathy
• Infiltrative Cardiomyopathy
• Myocarditis
• Pericardial Effusion
• Vascular Anomaly
• Vascular Malformations

Locations

Country	Name	City	State
Canada	McGill University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	SMART CMR scan completion percentage	Proportion of SMART CMR scans that could be completed according to the protocol	2019-2025
Secondary	OS-CMR scan completion percentage	Proportion of OS-CMR scans that could be completed according to the protocol	2019-2025
Secondary	Adverse event monitoring during SMART CMR sequences	Number and proportion of reported adverse events effects during SMART CMR	2019-2025
Secondary	Adverse event monitoring during OS-CMR sequence	Number and proportion of reported adverse events during OS-CMR	2019-2025
Secondary	SMART CMR sequence times vs standard protocol sequence times	Observed scan time for SMART CMR compared with the standard CMR protocol	2019-2025
Secondary	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
Secondary	Cost comparison of SMART CMR vs standard CMR protocol	Total estimated cost of SMART CMR compared with the standard CMR protocol	2019-2025
Secondary	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
Secondary	Septal myocardial T1 vs standard myocardial T1	Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping	2019-2025
Secondary	Septal myocardial T2 vs standard myocardial T2	Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping	2019-2025
Secondary	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
Secondary	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
Secondary	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
Secondary	Intra- and inter-reader reproducibility	Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.	2019-2025
Secondary	Inter- and intra-scanner variability	Inter- and intra- scanner variability as assessed by ICC and kappa	2019-2025