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Recruiting NCT04464655

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Observational Coronary Artery Disease Myocarditis Infiltrative Cardiomyopathy Dilated Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Myocarditis, Infiltrative Cardiomyopathy, Dilated Cardiomyopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Primary outcome measures

  • Primary diagnosis comparison between SMART CMR and standard CMR [Time frame: 2019-2025]
  • Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease [Time frame: 2019-2025]
Secondary outcome measures (12)
  • SMART CMR scan completion percentage [Time frame: 2019-2025]
  • OS-CMR scan completion percentage [Time frame: 2019-2025]
  • Adverse event monitoring during SMART CMR sequences [Time frame: 2019-2025]
  • Adverse event monitoring during OS-CMR sequence [Time frame: 2019-2025]
  • SMART CMR sequence times vs standard protocol sequence times [Time frame: 2019-2025]
  • OS-CMR sequence times vs standard protocol sequence times [Time frame: 2019-2025]
  • Cost comparison of SMART CMR vs standard CMR protocol [Time frame: 2019-2025]
  • Cost comparison of OS-CMR vs standard CMR protocol [Time frame: 2019-2025]
  • Septal myocardial T1 vs standard myocardial T1 [Time frame: 2019-2025]
  • Septal myocardial T2 vs standard myocardial T2 [Time frame: 2019-2025]
  • Quantitative parameter comparison between SMART CMR and CINE images [Time frame: 2019-2025]
  • Strain measurements vs standard cine image measurements [Time frame: 2019-2025]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Canada · 1 center
  • McGill University Health Center — Montreal

Identifiers

NCT: NCT04464655 · 2020-6128

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗