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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Prognostic Primary Objetive — Up to 2,5 years after AMI
  Incidence of cardiovascular mortality, hospitalizations due to heart failure and SVT according to the burden of NSVT detected in the first 6 months after AMI
• Incidence of NSVTs — First six months after AMI
  Incidence of NSVT during the first 6 months after an AMI in patients with an LVEF ≤40%.
• Evolution of the arrhythmic substrate by MRI — At six months after AMI
  Percetange of issue defined as scar, compact necrosis and heterogeneous tissue extensions (by cMRI and gadolinium delayed enhancement) in patients with/without NSVT episodes in the first 6 months after an AMI with LVEF ≤40%.

Trial sites (1)

More Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León trials in Spain

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