Coronary Artery DiseaseNCT04464655
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
An observational study of Coronary Artery Disease and Myocarditis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This study aims to identify and assess new CMR techniques that can improve current CMR protocols. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Myocarditis, Infiltrative Cardiomyopathy
- How many people
- 2,130 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2019to 31 Jan 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age: > 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system
- Age: >18 y, Informed consent, Clinically indicated CMR exam
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Center
Montreal, Quebec, H4A 3J1
Matthias G Friedrich, MD, 514-934-1934 ext. 62800, matthias.friedrich@mcgill.ca
Elizabeth Konidis, 514-934-1934 ext. 37305, elisavet.konidis@muhc.mcgill.ca
About this study
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
- Conditions
- Coronary Artery Disease, Myocarditis, Infiltrative Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiomyopathy, Aortic Valve Stenosis
- Medical subject headings
- Coronary Artery Disease, Myocarditis, Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Aortic Valve Stenosis, Aortic Valve Insufficiency, Pericardial Effusion, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2019-2025
Secondary outcomes (15)
SMART CMR scan completion percentage
Proportion of SMART CMR scans that could be completed according to the protocol
Measured: 2019-2025
OS-CMR scan completion percentage
Proportion of OS-CMR scans that could be completed according to the protocol
Measured: 2019-2025
Adverse event monitoring during SMART CMR sequences
Number and proportion of reported adverse events effects during SMART CMR
Measured: 2019-2025
Adverse event monitoring during OS-CMR sequence
Number and proportion of reported adverse events during OS-CMR
Measured: 2019-2025
SMART CMR sequence times vs standard protocol sequence times
Observed scan time for SMART CMR compared with the standard CMR protocol
Measured: 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
Measured: 2019-2025
Cost comparison of SMART CMR vs standard CMR protocol
Total estimated cost of SMART CMR compared with the standard CMR protocol
Measured: 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)
Measured: 2019-2025
Septal myocardial T1 vs standard myocardial T1
Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping
Measured: 2019-2025
Septal myocardial T2 vs standard myocardial T2
Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping
Measured: 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
Measured: 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
Measured: 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
Measured: 2019-2025
Intra- and inter-reader reproducibility
Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.
Measured: 2019-2025
Inter- and intra-scanner variability
Inter- and intra- scanner variability as assessed by ICC and kappa
Measured: 2019-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start12 Dec 2019
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Friedrich, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Matthias G Friedrich, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464655
- Sponsor's protocol ID
- 2020-6128
- Status last verified
- Oct 2024
- First submitted
- 6 Jul 2020
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No