Sudden Death Stratification

Completed

• Conditions: Non-ischemic Cardiomyopathy
• Interventions: Diagnostic Test: Cardiac MRI

• Registration Number: NCT04607265
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. While electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (LGE) cardiac MRI-3D reconstructions are now able to guide VT ablation procedures. Such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-09
• Study First Submitted: 2020-09-28
• Study First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Study First Posted: 2020-10-29
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult with NICM
• Previous history of ventricular tachycardia (VT) and no previous history of VT

Read More

Exclusion Criteria

• Inherited cardiomyopathies
• Previous history of myocarditis WITHOUT oedema/scar at the MRI

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventricular tachycardia (VT) group	Cardiac MRI	NICM patients admitted for a VT ablation with a pre-operative cardiac- MRI.
Control group	Cardiac MRI	NICM patients without ventricular arrhythmia and a previous cardiac-MRI. The matching with the VT group was based on the age of the patients, the mean LVEF, the time between the initial diagnosis and the MRI examination, and the origin of the NICM.

Primary Outcome Measures

Name	Time	Method
Detect pro arrhythmogenic scar characteristics	baseline : collected at the time of the cardiac MRI	The outcomes will aim to provide scar characteristics from 3D cardiac MRI reconstructions to detect pro arrhythmic properties in NICM patients. Comparisons between NICM patients who experienced VT ablation and NICM patients without history of ventricular arrhythmia will be made.; In both groups, Primary outcome will aim to measure the number of the conducting channels into scars (n).