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

Myocardial Infarction Clinical Trial

— TVScreen-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226234
• Other study ID #: 2021PI063
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: Christian de CHILLOU, MD, PhD
• Phone: +33383153126
• Email: c.dechillou[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• MRI
Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI)

Locations

Country	Name	City	State
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between the presence of the MRI criterion "intramural scar = 1.47cm²" measured by MRI and the occurrence of VT / VF after implantation of the ICD from the patient's medical record.	The area of the intramural scar will be determined from the MRI images. VT / VF events during the follow-up period will be reported from cardiac events recorded by the ICD and present in the patient's medical record.	5 years
Secondary	Association between the MRI criterion "intramural scar = 1.47cm²" measured by MRI and all-cause mortality from the patient's medical record.	The area of the intramural scar will be determined from the MRI images. All-cause mortality during the follow-up period will be collected from the patient's medical record.	5 years
Secondary	Association between the MRI criterion "intramural scar = 1.47cm²" measured by MRI and the combined criterion of all-cause mortality or occurrence of VT / VF from the patient's medical record.	The area of the intramural scar will be determined from the MRI images. VT / VF events and all-cause mortality during the follow-up period will be collected as described previously.	5 years