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NCT05226234: TVScreen-2
Risk Stratification of VT / VF After Myocardial Infarction Based on Cardiac MRI 2
trial testing MRI in Myocardial Infarction in 275 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 275 |
| Start date | 15 July 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across France |
Drugs / interventions tested
- MRI — full drug profile →
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
- Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
- Ventricular Fibrillation — all drugs for Ventricular Fibrillation →
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:
- PubMed search for NCT05226234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05226234 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 8 February 2023
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