Clinical Trial

Prognosis Impact of NSVTs After an AMI (TeVeO Study).

Study acronym: TeVeO
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Nowadays, Sudden Cardiac Death (SCD) due to malignant arrhythmias is an important cause of death among acute myocardial infarction (AMI) survivors. Preventive strategies with implantable cardioverter-defibrillators (ICD) are the best clinical option for patients, but associated sociosanitary impact in the National Health Systems and the fact that current implant strategy not always results in benefits for the patient requires to develop further selection criteria. The TeVeO project aims to study the events that take place early following an AMI to predict the short- and long-term risk of experiencing a potentially lethal ventricular tachycardia (VT). The project will carry out an observational and multicentric study involving 5 different hospitals to: a) qualitative and quantitative characterize non-sustained VTs (NSVT) that take place during the first 6 months after an AMI and b) characterize the evolution of the substrate (scar and surrounding tissue) in patients meeting criteria for ICD implant. Patients included in the study will be implanted with an implantable loop recorder (ILR) in order to register NSVT and cMRI images will be acquired prior to hospital discharge and at 6 months after AMI to study the substrate. Further patients' management will follow the protocols within each entity. Project results will allow us to stratify patients according to identified risks for developing malignant VT, which will improve patient selection for ICD implantation and will contribute to tailor patients' treatment and prevention, improving the cost-effectiveness of these devices and minimizing their associated problems and sociosanitary burden.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-02-18; most recent amendment 2025-03-20.
Status change: Recruiting → Active, Not Recruiting 2023-09-13
Trial Details
NCT Number NCT04765943
Lead Sponsor Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborators: Instituto de Salud Carlos III, Sanidad de Castilla y León, Spanish Society of Cardiology
Conditions Death, Sudden, Ventricular Tachycardia, Implantable Defibrillator User, Myocardial Infarction, Myocardial Dysfunction
Enrollment 224 participants
Start Date 2020-08-15
Primary Completion 2023-07-05 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-21