Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04765943

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

Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

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.

Official title: Analysis of the Incidence, Pathogeny and Prognostic Impact of the Non-sustained VT Registered by an Implantable Loop Recorder in the First 6 Months After an Acute Myocardial Infarction.TeVeO Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

224

Start Date

2020-08-15

Completion Date

2025-06-30

Last Updated

2025-03-21

Healthy Volunteers

No

Interventions

DEVICE

Implantable Loop Recorder implant

Patients will be undergone to an Implantable Loop Recorder implant and monitored for the next 6 months.They will then undergo a cardiac MRI and an ICD will be implanted according to clinical practice guidelines. A minimum follow-up of 2 years is scheduled.

Locations (1)

IBSAL-Hospital Universitario

Salamanca, Spain