Last reviewed · How we verify

NCT05226234: TVScreen-2

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

Status unknown Last updated 8 February 2023
What this trial tests

trial testing MRI in Myocardial Infarction in 275 participants. Status unknown.

Timeline
15 July 2022
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorCentral Hospital, Nancy, France
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment275
Start date15 July 2022
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Myocardial Infarction or Ventricular Tachycardia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of MRI

Trials testing the same drug.

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other Central Hospital, Nancy, France trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05226234.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing