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Sudden Death Stratification

NCT ID: NCT04607265

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Non-ischemic Cardiomyopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ventricular tachycardia (VT) group

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

Cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

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.

Cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiac MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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69HCL20_0838

Identifier Type: -

Identifier Source: org_study_id