Sudden Death Stratification

NCT04607265 | Completed

• 1 other identifier: 69HCL20_0838
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-ischemic Cardiomyopathy

Keywords

LGE MRI; Ventricular tachycardia; sudden cardiac death; non-ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Detect pro arrhythmogenic scar characteristics

  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).

  baseline : collected at the time of the cardiac MRI

Study Arms (2)

Ventricular tachycardia (VT) group

NICM patients admitted for a VT ablation with a pre-operative cardiac- MRI.

Diagnostic Test: Cardiac MRI

Control group

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.

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI DIAGNOSTIC_TEST

Comparison of scar characteristics on cardiac MRI between the two groups.

Control group; Ventricular tachycardia (VT) group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that underwent VT ablation, had a cardiac MRI prior to the ablation and suffered from non-ischemic cardiomyopathy (NICM) were included in the VT group. A 2:1 ratio of patients with non-ischemic cardiomyopathy and no history of ventricular tachycardia were included in the control group.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Tachycardia, Ventricular; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 29, 2020
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 29, 2020

Record last verified: 2020-09