Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2

NCT ID: NCT05226234

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-12-31

Brief Summary

Implantable cardioverter-defibrillators (ICD) are currently recommended (ESC guidelines 2015) for the primary prevention of sudden cardiac death (SCD) in patients with a remote myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF). Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. As a consequence, the current implantation strategy of prophylactic ICDs, based on LVEF, needs to be improved in post-MI patients. Stratification of the rhythmic risk after IDM is therefore still a major public health issue.

Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI) is a strong risk-stratifier of VT/VF risk in post- MI patients. In a recent multicenter retrospective study, the investigators showed that the presence of a critical surface of intramural scar (which is consequently neither epicardial nor endocardial) at the infarct border (measured by LGE-MRI) has a major association with the occurrence of VT/VF in post-MI patients with a LVEF≤35%.

The aim of the TVScreen 2 study is therefore to validate the relevance of the MRI criterion in a new independent cohort of patients.

Conditions

Myocardial Infarction; Ventricular Tachycardia; Ventricular Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Experimental group

MRI

Intervention Type: DEVICE

Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI)

Interventions

MRI

Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Person who has received full information on the organization of the research and who has not objected to the use of this data;
• Person having had an ICD implantation for primary prevention before 12/31/2017 after myocardial infarction;
• Person with LVEF ≤35% at the time of ICD implantation.

Exclusion Criteria

• Patient with a history of persistent atrial fibrillation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Christian DE CHILLOU

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHRU de Nancy

Nancy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christian de CHILLOU, MD, PhD

Role: CONTACT

c.dechillou@chru-nancy.fr

+33383153126 ext. +33

Guillaume DROUOT, PhD

Role: CONTACT

g.drouot@chru-nancy.fr

+33383157666 ext. +33

Facility Contacts

Guillaume DROUOT, PhD

Role: primary

g.drouot@chru-nancy.fr

+33383157666 ext. +33

Other Identifiers

2021PI063

Identifier Type: -

Identifier Source: org_study_id