NCT04765943Active, not recruiting
Prognosis Impact of NSVTs After an AMI (TeVeO Study).
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.
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 224 (actual)
- First submitted
- 16 Feb 2021
- Start date
- 15 Aug 2020
- Primary completion date
- 5 Jul 2023
- Lead sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Diseases
- Coronary artery disease
- NCT number
- NCT04765943
What you commit to
- Study type: Observational
- Participants enrolled: 224
- From 15 Aug 2020 to the primary completion date, 5 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant valvulopathy with indication for surgery.
Other illness
- Patient already implanted with a cardiac device (pacemaker, ICD or ICD-TRC).
- Allergy or hypersensitivity to any implatable device component.
- Life expectancy under 1 year due to a non-cardiac cause.
Other
- Non-ischemic etiology of left ventricular dysfunction by cMRI.
- Indication of pacemaker, ICD or ICD-TRC implantation during hospitalization.
- Contraindication for cMRI performance.
- High functional class (NYHA IV).
- No possibility to connect to the remote monitoring.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IBSAL-Hospital Universitario Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.