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

NCT04765943 | Active Not Recruiting

• 1 other identifier: PI19/0065
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Unsustained ventricular tachycardia; Implantable loop recorder; Appropriate therapy

Outcome Measures

Primary Outcomes (3)

• Prognostic Primary Objetive

  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

  Up to 2,5 years after AMI

• Incidence of NSVTs

  Incidence of NSVT during the first 6 months after an AMI in patients with an LVEF ≤40%.

  First six months after AMI

• Evolution of the arrhythmic substrate by MRI

  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%.

  At six months after AMI

Secondary Outcomes (2)

• Accuracy secondary objective.

  Up to 2,5 years after AMI

• Clinical secondary objective.

  Up to 2,5 years after AMI

Study Arms (1)

Study population

Patients with LVEF equal to or less than 40% determined by echocardiogram on the 4th day after acute myocardial infarction.

Device: Implantable Loop Recorder implant

Interventions

Implantable Loop Recorder implant DEVICE

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 population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unselected patients who have suffered a myocardial infarction and who have an LVEF equal to or less than 40% (determined by transthoracic echocardiography) on the fourth day after the event.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead
• Instituto de Salud Carlos III: collaborator
• Sanidad de Castilla y León: collaborator
• Spanish Society of Cardiology: collaborator

Study Sites (1)

IBSAL-Hospital Universitario

Salamanca, 37007, Spain

Location

Related Publications (1)

• Hernandez-Hernandez J, Cruz-Galban A, Duran-Bobin O, Garcia-Seara J, Gonzalez-Ferrero T, Morinigo J, Gonzalez-Juanatey C, Sanchez-Garcia M, Fernandez-Palacios G, Seijas-Amigo J, Elices J, Portales-Fernandez J, Martin-Herrero F, Garcia-Campos A, Perez-Rivera JA, Martin-Garcia A, Alonso-Fernandez-Gatta M, Macias A, Perez-Espejo P, Garcia-Fernandez J, Sanchez PL, Jimenez-Candil J. Prospective study of continuous rhythm monitoring in patients with early post-infarction systolic dysfunction: clinical impact of arrhythmias detected by an implantable cardiac monitoring device with real-time transmission-the TeVeO study protocol. BMJ Open. 2025 May 2;15(5):e094764. doi: 10.1136/bmjopen-2024-094764.

  PMID: 40316360 DERIVED

MeSH Terms

Conditions

Death, Sudden; Tachycardia, Ventricular; Myocardial Infarction

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Arrhythmias Unit. Cardiology Department. IBSAL-Hospital Universitario de Salamanca

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 23, 2021
• Study Start: August 15, 2020
• Primary Completion: July 5, 2023
• Study Completion: June 30, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Information will be available to the scientific community 6 months after publication.
• Access Criteria: After the application, the research quality and experience of the applicant group will be evaluated, prioritizing only solvent groups with experience in the field. Data will be provided to clarify the results presented in the publication.

Locations

ES (1)