A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

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

Detailed Description
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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

Official Title
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A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Age: >18 y, No known current or pre-existing medical conditions that would affect the cardiovascular or respiratory system. | |
| Patients<br>Age: > 18y, Clinically indicated CMR exam | |

What is the study measuring?
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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 |