MedTrace Logo

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

NCT04765943 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 224

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Death, Sudden
  • Ventricular Tachycardia
  • Implantable Defibrillator User
  • Myocardial Infarction
  • Myocardial Dysfunction

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Sanidad de Castilla y León

    collaborator OTHER

  • Spanish Society of Cardiology

    collaborator OTHER

  • Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-15
Primary Completion
2023-07-05
Completion
2025-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04765943 on ClinicalTrials.gov