A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

NCT04464655 | Recruiting

• 1 other identifier: 2020-6128
• Study Type: observational
• Target: 2,130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2019-2025

Secondary Outcomes (15)

• SMART CMR scan completion percentage

  2019-2025

• OS-CMR scan completion percentage

  2019-2025

• Adverse event monitoring during SMART CMR sequences

  2019-2025

• Adverse event monitoring during OS-CMR sequence

  2019-2025

• SMART CMR sequence times vs standard protocol sequence times

  2019-2025

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• 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.
• Regular nicotine consumption during the last 6 months

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocarditis; Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Aortic Valve Stenosis; Aortic Valve Insufficiency; Pericardial Effusion; Heart Defects, Congenital; Vascular Malformations

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiomyopathies; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Stenosis, Subvalvular; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiovascular Abnormalities; Congenital Abnormalities

Study Officials

• Matthias G Friedrich, MD

  Research Institute of the McGill University Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Konidis

CONTACT

514-934-1934; elisavet.konidis@muhc.mcgill.ca

Adonis Rodaros

CONTACT

514-934-1934; adonis.rodaros@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: December 12, 2019
• Primary Completion: November 30, 2024
• Study Completion: January 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

CA (1)