A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Age: >18 y, Informed consent, Clinically indicated CMR exam

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,130 Participants
are grouped into 2 trial groups
Group A: Healthy Volunteers
Group B: Patients

Trial outcomes

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

Other outcomes

Sponsors and contacts

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