A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
- Conditions
- Coronary Artery DiseaseMyocarditisInfiltrative CardiomyopathyDilated CardiomyopathyAortic Valve StenosisCongenital Heart DiseaseAortic Valve RegurgitationPericardial EffusionVascular AnomalyHypertrophic Cardiomyopathy
- Registration Number
- NCT04464655
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2130
- Age: > 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease 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 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.
- Secondary Outcome Measures
Name Time Method SMART CMR scan completion percentage 2019-2025 Proportion of SMART CMR scans that could be completed according to the protocol
Adverse event monitoring during SMART CMR sequences 2019-2025 Number and proportion of reported adverse events effects during SMART CMR
Adverse event monitoring during OS-CMR sequence 2019-2025 Number and proportion of reported adverse events during OS-CMR
OS-CMR scan completion percentage 2019-2025 Proportion of OS-CMR scans that could be completed according to the protocol
SMART CMR sequence times vs standard protocol sequence times 2019-2025 Observed scan time for SMART CMR compared with the standard CMR protocol
Septal myocardial T2 vs standard myocardial T2 2019-2025 Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping
OS-CMR sequence times vs standard protocol sequence times 2019-2025 Observed scan time for for OS-CMR during breathing maneuvers compared with the standard CMR first-pass perfusion protocol
Cost comparison of OS-CMR vs standard CMR protocol 2019-2025 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)
Septal myocardial T1 vs standard myocardial T1 2019-2025 Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping
SMART-CMR post-stenotic peak flow vs standard CMR flow images 2019-2025 Post-stenotic peak flow velocity in patients with suspected valvular disease measured in SMART CMR images, compared with results from standard CMR flow images
Inter- and intra-scanner variability 2019-2025 Inter- and intra- scanner variability as assessed by ICC and kappa
Cost comparison of SMART CMR vs standard CMR protocol 2019-2025 Total estimated cost of SMART CMR compared with the standard CMR protocol
Intra- and inter-reader reproducibility 2019-2025 Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.
Quantitative parameter comparison between SMART CMR and CINE images 2019-2025 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
Strain measurements vs standard cine image measurements 2019-2025 Longitudinal and circumferential strain measurements measured in SMART CMR images, compared with results from standard CMR cine images
Trial Locations
- Locations (1)
McGill University Health Center
🇨🇦Montreal, Quebec, Canada