Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2
- Conditions
- Ventricular FibrillationMyocardial InfarctionVentricular Tachycardia
- Interventions
- Device: MRI
- Registration Number
- NCT05226234
- Lead Sponsor
- Central Hospital, Nancy, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 275
- 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.
- Patient with a history of persistent atrial fibrillation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental group MRI -
- Primary Outcome Measures
Name Time Method 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. 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 Outcome Measures
Name Time Method Association between the MRI criterion "intramural scar ≥ 1.47cm²" measured by MRI and all-cause mortality from the patient's medical record. 5 years 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.
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 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.
Trial Locations
- Locations (1)
CHRU de Nancy
🇫🇷Nancy, France