Active — Not RecruitingNot Applicable

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

Spain224 participantsStarted 2020-08-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * AMI patients over 18 years old. * LVEF equal or lower than 40% determined by a transthoracic echocardiography 4 days after the onset of the AMI. * Revascularization during hospitalization according to the clinical practice guidelines * Signed informed consent. Exclusion Criteria: * Non-ischemic etiology of left ventricular dysfunction by cMRI. * Patient already implanted with a cardiac device (pacemaker, ICD or ICD-TRC). * Indication of pacemaker, ICD or ICD-TRC implantation during hospitalization. * Allergy or hypersensitivity to any implatable device component. * Contraindication for cMRI performance. * Life expectancy under 1 year due to a non-cardiac cause. * Concomitant valvulopathy with indication for surgery. * High functional class (NYHA IV). * No possibility to connect to the remote monitoring.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prognostic Primary Objetive

Timeframe: Up to 2,5 years after AMI

Incidence of NSVTs

Timeframe: First six months after AMI

Evolution of the arrhythmic substrate by MRI

Timeframe: At six months after AMI

Trial details

NCT IDNCT04765943

SponsorFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-07-05

View on ClinicalTrials.gov More Death, Sudden trials