ClinicalTrials.gg
RecruitingNCT04464655Updated Nov 4, 2026

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

An observational study in Coronary Artery Disease, Myocarditis and Infiltrative Cardiomyopathy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational

From the registry’s dates

  • Started Dec 2019; still recruiting 6 years 10 months later.
Updated Nov 4, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,130
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Coronary Artery Disease
  • Myocarditis
  • Infiltrative Cardiomyopathy
  • Dilated Cardiomyopathy
  • Hypertrophic Cardiomyopathy
  • Aortic Valve Stenosis
  • Aortic Valve Regurgitation
  • Pericardial Effusion
  • Congenital Heart Disease
  • Vascular Anomaly
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 2,130 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Eligibility criteria

Healthy Volunteers

Inclusion Criteria:

  • Age: > 18y, No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system

Exclusion Criteria:

  • General MRI : 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,130 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2019-2025

  2. 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.

    Time frame: 2019-2025

Secondary outcomes

  1. SMART CMR scan completion percentage

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

    Time frame: 2019-2025

  2. OS-CMR scan completion percentage

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

    Time frame: 2019-2025

  3. Adverse event monitoring during SMART CMR sequences

    Number and proportion of reported adverse events effects during SMART CMR

    Time frame: 2019-2025

  4. Adverse event monitoring during OS-CMR sequence

    Number and proportion of reported adverse events during OS-CMR

    Time frame: 2019-2025

  5. SMART CMR sequence times vs standard protocol sequence times

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

    Time frame: 2019-2025

  6. 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

    Time frame: 2019-2025

  7. Cost comparison of SMART CMR vs standard CMR protocol

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

    Time frame: 2019-2025

  8. 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)

    Time frame: 2019-2025

  9. Septal myocardial T1 vs standard myocardial T1

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

    Time frame: 2019-2025

  10. Septal myocardial T2 vs standard myocardial T2

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

    Time frame: 2019-2025

  11. 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

    Time frame: 2019-2025

  12. 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

    Time frame: 2019-2025

  13. 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

    Time frame: 2019-2025

  14. Intra- and inter-reader reproducibility

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

    Time frame: 2019-2025

  15. Inter- and intra-scanner variability

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

    Time frame: 2019-2025

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2019 (actual). Primary completion is estimated for Dec 2026, 84 months after the start.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 84 months is above that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Nov 2024 → Dec 2026 and completion Jan 2025 → May 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2020
First posted
Jul 9, 2020
StartActual
Dec 12, 2019
Primary completionEst.
Dec 19, 2026was Nov 2024
CompletionEst.
May 1, 2027was Jan 2025
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Nov 30, 2024→Dec 19, 2026
Nov 4, 2026
Study completion
Jan 31, 2025→May 1, 2027
Nov 4, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • McGill University Health Center · Montreal, CanadaContact person changed (no phone or email listed)
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Primary completion Nov 30, 2024→Dec 19, 2026
    Study completion Jan 31, 2025→May 1, 2027
    Site contacts Changed at 1 site. See the sites
    Show the site
    • McGill University Health Center · Montreal, CanadaContact person changed (no phone or email listed)
    + 3 other changes: verification date, oversight details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04464655
Responsible party
Matthias Friedrich (Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Jul 9, 2020
Start date
Dec 12, 2019
Primary completion
Dec 19, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Elizabeth Konidis
Contact
elisavet.konidis@muhc.mcgill.ca
514-934-1934 ext. 37305
Adonis Rodaros
Contact
adonis.rodaros@muhc.mcgill.ca
514-934-1934 ext. 37305
Matthias G Friedrich, MD
principal investigator · McGill University Health Centre/Research Institute of the McGill University Health Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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