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A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464655
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Matthias Friedrich, 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.

Condition or disease
Coronary Artery Disease Myocarditis Infiltrative Cardiomyopathy Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Aortic Valve Stenosis Aortic Valve Regurgitation Pericardial Effusion Congenital Heart Disease Vascular Anomaly

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

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Study Type : Observational
Estimated Enrollment : 2130 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : January 31, 2025


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464655


Contacts
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Contact: Elizabeth Konidis 514-934-1934 ext 37305 elisavet.konidis@muhc.mcgill.ca
Contact: Adonis Rodaros 514-934-1934 ext 37305 adonis.rodaros@muhc.mcgill.ca

Locations
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Canada, Quebec
McGill University Health Center Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Matthias G Friedrich, MD    514-934-1934 ext 62800    matthias.friedrich@mcgill.ca   
Contact: Elizabeth Konidis    514-934-1934 ext 37305    elisavet.konidis@muhc.mcgill.ca   
Sub-Investigator: Katerina Eyre, PhD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Matthias G Friedrich, MD Research Institute of the McGill University Health Center
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Responsible Party: Matthias Friedrich, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT04464655    
Other Study ID Numbers: 2020-6128
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Diseases
Coronary Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases
Cardiomyopathies
Aortic Valve Stenosis
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Myocarditis
Pericardial Effusion
Vascular Malformations
Aortic Valve Insufficiency
Myocardial Ischemia
Arteriosclerosis
Ventricular Outflow Obstruction
Congenital Abnormalities
Aortic Stenosis, Subvalvular
Cardiomegaly
Cardiovascular Abnormalities