Sudden Death Stratification

October 22, 2020 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ventricular tachycardia (VT) group
NICM patients admitted for a VT ablation with a pre-operative cardiac- MRI.
Diagnostic test: Cardiac MRI
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.
Diagnostic test: Cardiac MRI
Comparison of scar characteristics on cardiac MRI between the two groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect pro arrhythmogenic scar characteristics
Time Frame: 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).
baseline : collected at the time of the cardiac MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 28, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0838

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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