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

NCT05226234 | Unknown

• 1 other identifier: 2021PI063
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Ventricular Tachycardia; Ventricular Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Experimental group

Device: MRI

Interventions

MRI DEVICE

Late gadolinium enhancement cardiac magnetic resonance (LGE-MRI)

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient with a history of persistent atrial fibrillation.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU de Nancy

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease

Central Study Contacts

Christian de CHILLOU, MD, PhD

CONTACT

+33383153126; c.dechillou@chru-nancy.fr

Guillaume DROUOT, PhD

CONTACT

+33383157666; g.drouot@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 7, 2022
• Study Start: July 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)