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NCT Number: NCT04464655

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.

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Key information

Conditions

Coronary Artery Disease Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Dilated Cardiomyopathy Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Heart Valve Diseases Hypertrophic Cardiomyopathy Infiltrative Cardiomyopathy Laminopathies Myocardial Ischemia Myocarditis Pericardial Effusion Vascular Anomaly Vascular Diseases Vascular Malformations Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. SMART CMR scan completion percentage

    Time frame: 2019-2025

    Proportion of SMART CMR scans that could be completed according to the protocol

  2. OS-CMR scan completion percentage

    Time frame: 2019-2025

    Proportion of OS-CMR scans that could be completed according to the protocol

  3. Adverse event monitoring during SMART CMR sequences

    Time frame: 2019-2025

    Number and proportion of reported adverse events effects during SMART CMR

  4. Adverse event monitoring during OS-CMR sequence

    Time frame: 2019-2025

    Number and proportion of reported adverse events during OS-CMR

  5. SMART CMR sequence times vs standard protocol sequence times

    Time frame: 2019-2025

    Observed scan time for SMART CMR compared with the standard CMR protocol

  6. OS-CMR sequence times vs standard protocol sequence times

    Time frame: 2019-2025

    Observed scan time for for OS-CMR during breathing maneuvers compared with the standard CMR first-pass perfusion protocol

  7. Cost comparison of SMART CMR vs standard CMR protocol

    Time frame: 2019-2025

    Total estimated cost of SMART CMR compared with the standard CMR protocol

  8. Cost comparison of OS-CMR vs standard CMR protocol

    Time frame: 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)

  9. Septal myocardial T1 vs standard myocardial T1

    Time frame: 2019-2025

    Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping

  10. Septal myocardial T2 vs standard myocardial T2

    Time frame: 2019-2025

    Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping

  11. Quantitative parameter comparison between SMART CMR and CINE images

    Time frame: 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

  12. Strain measurements vs standard cine image measurements

    Time frame: 2019-2025

    Longitudinal and circumferential strain measurements measured in SMART CMR images, compared with results from standard CMR cine images

  13. SMART-CMR post-stenotic peak flow vs standard CMR flow images

    Time frame: 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

  14. Intra- and inter-reader reproducibility

    Time frame: 2019-2025

    Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.

  15. Inter- and intra-scanner variability

    Time frame: 2019-2025

    Inter- and intra- scanner variability as assessed by ICC and kappa

Study contacts

Contact information is provided by the study sponsor or research team.

Adonis Rodaros

CONTACT

[email protected]

514-934-1934 ext. 37305

Elizabeth Konidis

CONTACT

[email protected]

514-934-1934 ext. 37305

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jul 9, 2020
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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