Sudden Death Stratification

Non-ischemic Cardiomyopathy Clinical Trial

Official title:

Channel Detection to Predict Ventricular Arrhythmia in Patients With Non-ischemic Cardiomyopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607265
• Other study ID #: 69HCL20_0838
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: September 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Non-ischemic Cardiomyopathy

Intervention

Diagnostic Test:
• Cardiac MRI
Comparison of scar characteristics on cardiac MRI between the two groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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