Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 275
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Christian DE CHILLOU
Principal Investigator
Central Hospital, Nancy, France
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.
Outcomes
Primary Outcomes
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.
Time Frame: 5 years
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.
Secondary Outcomes
- Association between the MRI criterion "intramural scar ≥ 1.47cm²" measured by MRI and all-cause mortality from the patient's medical record.(5 years)
- 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.(5 years)