TVScreen-2: Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental group
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Device: MRI
Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Person who has received full information on the organization of the research and who has not objected to the use of this data;
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Person having had an ICD implantation for primary prevention before 12/31/2017 after myocardial infarction;
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Person with LVEF ≤35% at the time of ICD implantation.
Exclusion Criteria:
- Patient with a history of persistent atrial fibrillation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU de Nancy | Nancy | France | 54000 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021PI063