<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04464655</url>
  </required_header>
  <id_info>
    <org_study_id>2020-6128</org_study_id>
    <nct_id>NCT04464655</nct_id>
  </id_info>
  <brief_title>A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease</brief_title>
  <official_title>A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to identify and assess new CMR techniques that can improve current CMR&#xD;
      protocols.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to develop a comprehensive 10-minute protocol based on function and&#xD;
      myocardial tissue characterization without the need for contrast injection, which can be&#xD;
      standardized for 70% of cardiac patients.&#xD;
&#xD;
      To test this 10-minute CMR protocol for its ability to significantly improve diagnostic&#xD;
      decision-making and to reduce cost.&#xD;
&#xD;
      To test its clinical feasibility, performance and cost-effectiveness in different populations&#xD;
      including: Non-ischemic cardiomyopathies (-)OS-CMR and Ischemic Heart Disease and CAD&#xD;
      (+)OS-CMR&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 12, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary diagnosis comparison between SMART CMR and standard CMR</measure>
    <time_frame>2019-2025</time_frame>
    <description>(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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease</measure>
    <time_frame>2019-2025</time_frame>
    <description>(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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SMART CMR scan completion percentage</measure>
    <time_frame>2019-2025</time_frame>
    <description>Proportion of SMART CMR scans that could be completed according to the protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS-CMR scan completion percentage</measure>
    <time_frame>2019-2025</time_frame>
    <description>Proportion of OS-CMR scans that could be completed according to the protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event monitoring during SMART CMR sequences</measure>
    <time_frame>2019-2025</time_frame>
    <description>Number and proportion of reported adverse events effects during SMART CMR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event monitoring during OS-CMR sequence</measure>
    <time_frame>2019-2025</time_frame>
    <description>Number and proportion of reported adverse events during OS-CMR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SMART CMR sequence times vs standard protocol sequence times</measure>
    <time_frame>2019-2025</time_frame>
    <description>Observed scan time for SMART CMR compared with the standard CMR protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS-CMR sequence times vs standard protocol sequence times</measure>
    <time_frame>2019-2025</time_frame>
    <description>Observed scan time for for OS-CMR during breathing maneuvers compared with the standard CMR first-pass perfusion protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost comparison of SMART CMR vs standard CMR protocol</measure>
    <time_frame>2019-2025</time_frame>
    <description>Total estimated cost of SMART CMR compared with the standard CMR protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost comparison of OS-CMR vs standard CMR protocol</measure>
    <time_frame>2019-2025</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Septal myocardial T1 vs standard myocardial T1</measure>
    <time_frame>2019-2025</time_frame>
    <description>Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Septal myocardial T2 vs standard myocardial T2</measure>
    <time_frame>2019-2025</time_frame>
    <description>Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative parameter comparison between SMART CMR and CINE images</measure>
    <time_frame>2019-2025</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strain measurements vs standard cine image measurements</measure>
    <time_frame>2019-2025</time_frame>
    <description>Longitudinal and circumferential strain measurements measured in SMART CMR images, compared with results from standard CMR cine images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SMART-CMR post-stenotic peak flow vs standard CMR flow images</measure>
    <time_frame>2019-2025</time_frame>
    <description>Post-stenotic peak flow velocity in patients with suspected valvular disease measured in SMART CMR images, compared with results from standard CMR flow images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra- and inter-reader reproducibility</measure>
    <time_frame>2019-2025</time_frame>
    <description>Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter- and intra-scanner variability</measure>
    <time_frame>2019-2025</time_frame>
    <description>Inter- and intra- scanner variability as assessed by ICC and kappa</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">2130</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Myocarditis</condition>
  <condition>Infiltrative Cardiomyopathy</condition>
  <condition>Dilated Cardiomyopathy</condition>
  <condition>Hypertrophic Cardiomyopathy</condition>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Aortic Valve Regurgitation</condition>
  <condition>Pericardial Effusion</condition>
  <condition>Congenital Heart Disease</condition>
  <condition>Vascular Anomaly</condition>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Age: &gt;18 y, No known current or pre-existing medical conditions that would affect the cardiovascular or respiratory system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Age: &gt; 18y, Clinically indicated CMR exam</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be composed of patients with suspected cardiovascular disease who&#xD;
        are scheduled for a clinical CMR scan as part of a routine clinical work-up.&#xD;
&#xD;
        Patients will be stratified according to the clinical indication for CMR and their&#xD;
        suspected or known clinical diagnosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Healthy Volunteers&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: &gt; 18y, Informed consent No known current or pre-existing significant medical&#xD;
             conditions that would affect the cardiovascular or respiratory system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General MRI contraindications: MR- incompatible devices such as pacemakers,&#xD;
             defibrillators, or implanted material or foreign bodies. Consumption of caffeinated&#xD;
             drinks or foods (including cocoa and chocolate) during the 12 hours prior to the&#xD;
             exam.Regular nicotine consumption during the last 6 months&#xD;
&#xD;
        Patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: &gt;18 y, Informed consent, Clinically indicated CMR exam&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General MRI contraindications: MR- incompatible devices such as pacemakers,&#xD;
             defibrillators, or implanted material or foreign bodies Vasoactive medication (e.g.&#xD;
             nitro) during the 12 hours prior to the exam. Consumption of caffeinated drinks or&#xD;
             foods (including cocoa and chocolate) during the 12 hours prior to the exam.&#xD;
&#xD;
        Regular nicotine consumption during the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias G Friedrich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Institute of the McGill University Health Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Konidis</last_name>
    <phone>514-934-1934</phone>
    <phone_ext>37305</phone_ext>
    <email>elisavet.konidis@muhc.mcgill.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adonis Rodaros</last_name>
    <phone>514-934-1934</phone>
    <phone_ext>37305</phone_ext>
    <email>adonis.rodaros@muhc.mcgill.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>McGill University Health Center</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthias G Friedrich, MD</last_name>
      <phone>514-934-1934</phone>
      <phone_ext>62800</phone_ext>
      <email>matthias.friedrich@mcgill.ca</email>
    </contact>
    <contact_backup>
      <last_name>Elizabeth Konidis</last_name>
      <phone>514-934-1934</phone>
      <phone_ext>37305</phone_ext>
      <email>elisavet.konidis@muhc.mcgill.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Katerina Eyre, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Matthias Friedrich</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Cardiomyopathy, Dilated</mesh_term>
    <mesh_term>Myocarditis</mesh_term>
    <mesh_term>Pericardial Effusion</mesh_term>
    <mesh_term>Vascular Malformations</mesh_term>
    <mesh_term>Aortic Valve Insufficiency</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04464655
org study id: 2020-6128
nct id: NCT04464655
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to identify and assess new CMR techniques that can improve current CMR
      protocols.
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
observational model: Other
time perspective: Prospective
measure: Primary diagnosis comparison between SMART CMR and standard CMR
time frame: 2019-2025
description: (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.
measure: Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease
time frame: 2019-2025
description: (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.
measure: SMART CMR scan completion percentage
time frame: 2019-2025
description: Proportion of SMART CMR scans that could be completed according to the protocol
measure: OS-CMR scan completion percentage
time frame: 2019-2025
description: Proportion of OS-CMR scans that could be completed according to the protocol
measure: Adverse event monitoring during SMART CMR sequences
time frame: 2019-2025
description: Number and proportion of reported adverse events effects during SMART CMR
measure: Adverse event monitoring during OS-CMR sequence
time frame: 2019-2025
description: Number and proportion of reported adverse events during OS-CMR
measure: SMART CMR sequence times vs standard protocol sequence times
time frame: 2019-2025
description: Observed scan time for SMART CMR compared with the standard CMR protocol
measure: OS-CMR sequence times vs standard protocol sequence times
time frame: 2019-2025
description: Observed scan time for for OS-CMR during breathing maneuvers compared with the standard CMR first-pass perfusion protocol
measure: Cost comparison of SMART CMR vs standard CMR protocol
time frame: 2019-2025
description: Total estimated cost of SMART CMR compared with the standard CMR protocol
measure: Cost comparison of OS-CMR vs standard CMR protocol
time frame: 2019-2025
description: 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)
measure: Septal myocardial T1 vs standard myocardial T1
time frame: 2019-2025
description: Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping
measure: Septal myocardial T2 vs standard myocardial T2
time frame: 2019-2025
description: Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping
measure: Quantitative parameter comparison between SMART CMR and CINE images
time frame: 2019-2025
description: 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
measure: Strain measurements vs standard cine image measurements
time frame: 2019-2025
description: Longitudinal and circumferential strain measurements measured in SMART CMR images, compared with results from standard CMR cine images
measure: SMART-CMR post-stenotic peak flow vs standard CMR flow images
time frame: 2019-2025
description: Post-stenotic peak flow velocity in patients with suspected valvular disease measured in SMART CMR images, compared with results from standard CMR flow images
measure: Intra- and inter-reader reproducibility
time frame: 2019-2025
description: Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.
measure: Inter- and intra-scanner variability
time frame: 2019-2025
description: Inter- and intra- scanner variability as assessed by ICC and kappa
arm group label: Healthy Volunteers
description: Age: >18 y, No known current or pre-existing medical conditions that would affect the cardiovascular or respiratory system.
arm group label: Patients
description: Age: > 18y, Clinically indicated CMR exam
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias G Friedrich, MD
role: Principal Investigator
affiliation: Research Institute of the McGill University Health Center
last name: Elizabeth Konidis
phone: 514-934-1934
phone ext: 37305
email: elisavet.konidis@muhc.mcgill.ca
last name: Adonis Rodaros
phone: 514-934-1934
phone ext: 37305
email: adonis.rodaros@muhc.mcgill.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Matthias Friedrich
investigator title: Principal Investigator
mesh term: Coronary Artery Disease
mesh term: Heart Diseases
mesh term: Cardiomyopathies
mesh term: Heart Defects, Congenital
mesh term: Aortic Valve Stenosis
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Cardiomyopathy, Dilated
mesh term: Myocarditis
mesh term: Pericardial Effusion
mesh term: Vascular Malformations
mesh term: Aortic Valve Insufficiency