IMAGE-HF: Project IIa Canadian CArdiomyopathy Registry for Device Therapy (CanCARD-MR)

IMAGE-HF: Project IIa - Canadian CArdiomyopathy Registry for Device Therapy (CanCARD-MR)

Delayed enhanced MRI in patients (of either ischemic or non-ischemic cause) being referred for primary prevention ICD

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure

Detailed Description

Device therapy using defibrillators and cardiac resynchronization therapy (CRT) is an important advance in the care of patients with acquired heart disease and heart failure. In specific groups these devices appear to significantly reduce the risk of sudden cardiac death and progression of heart failure. However, our ability to identify ideal candidates, and those who are most likely to respond and benefit from this therapy, is poor.

Preliminary studies using specialized Magnetic Resonance Imaging (MRI) appears to be one of the more valuable ways of predicting response to device therapy and holds substantial promise for patients with cardiomyopathy.

Large, prospective registries are necessary to explore its real-world utility for risk prediction across a broad spectrum of patients. Can-CARD MR is a national, multi-centre registry designed to address this particular need.

• Study Type: Observational
• Enrollment (Actual): 502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for or being considered for primary prevention ICD, with or without CRT, will be recruited from the Electrophysiology services at each enrolling site

Description

Inclusion Criteria:

• .Any patient accepted for primary prevention ICD (+/-) CRT)

Exclusion Criteria:

• Known contra-indications to MRI.
• Recent myocardial infarction or revascularization procedure within the past 3 months.
• GFR (glomerular filtration rate) ≤ 30 ml. / min/ m2.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death	Occurrence of a)appropriate ICD therapy (shock or anti-tachycardia pacing (ATP)) or sudden cardiac death	1 year

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: David Birnie, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2011
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: 2011308-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No