Clinical trial NCT04464655: A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Official title: A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Myocarditis
Infiltrative Cardiomyopathy
Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Aortic Valve Stenosis
Aortic Valve Regurgitation
Pericardial Effusion
Congenital Heart Disease
Vascular Anomaly
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 2130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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

Eligibility 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

Primary outcomes:
measure: Primary diagnosis comparison between SMART CMR and standard CMR
timeFrame: 2019-2025
measure: Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease
timeFrame: 2019-2025
Secondary outcomes:
measure: SMART CMR scan completion percentage
timeFrame: 2019-2025
measure: OS-CMR scan completion percentage
timeFrame: 2019-2025
measure: Adverse event monitoring during SMART CMR sequences
timeFrame: 2019-2025
measure: Adverse event monitoring during OS-CMR sequence
timeFrame: 2019-2025
measure: SMART CMR sequence times vs standard protocol sequence times
timeFrame: 2019-2025
measure: OS-CMR sequence times vs standard protocol sequence times
timeFrame: 2019-2025
measure: Cost comparison of SMART CMR vs standard CMR protocol
timeFrame: 2019-2025
measure: Cost comparison of OS-CMR vs standard CMR protocol
timeFrame: 2019-2025
measure: Septal myocardial T1 vs standard myocardial T1
timeFrame: 2019-2025
measure: Septal myocardial T2 vs standard myocardial T2
timeFrame: 2019-2025
measure: Quantitative parameter comparison between SMART CMR and CINE images
timeFrame: 2019-2025
measure: Strain measurements vs standard cine image measurements
timeFrame: 2019-2025
measure: SMART-CMR post-stenotic peak flow vs standard CMR flow images
timeFrame: 2019-2025
measure: Intra- and inter-reader reproducibility
timeFrame: 2019-2025
measure: Inter- and intra-scanner variability
timeFrame: 2019-2025
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Center
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Center
name: Matthias G Friedrich, MD
role: PRINCIPAL_INVESTIGATOR
References: