Clinical trial NCT05226234: Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2
Official title: Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a history of myocardial infarction with LVEF ≤35%, implantation of an ICD for primary prevention before 12/31/2017 and the performance of a cardiac MRI.

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: Association between the MRI criterion "intramural scar ≥ 1.47cm²" measured by MRI and all-cause mortality from the patient's medical record.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: