Resumen

INTRODUCTION: Sudden cardiac death is one of the most important reasons of death at industrialized countries. Despite its importance, nowadays Clinical Guidelines are not as extended as expected, with respect to indications for primary prevention defibrillator implantation, following MADIT II and MUSTT criteria, especially at Latin American countries. OBJECTIVES: This Project is designed with the purpose of providing tools to help spreading primary prevention by the means of clinical evidence on real risk of death in this group of patients. REGISTRY DESIGN: * retrospective (at stage 1); prospective (at stage 2) * multi-center (minimum 25-30 centres) * international (Argentina, Brazil, Colombia, Chile, Mexico and Venezuela) * non randomized. * Sample size: at screening about 12.500 patients and 962 patients at treatment stage REGISTRY DEVICES: CE marked (Conformité Européenne) single-chamber, dual-chamber or CRT (Cardiac Resynchronization Therapy) implantable cardiac defibrillator (ICD).

Descripción detallada

REGISTRY STAGES 2 stages will be performed: * Stage 1 (Screening): 12500 patients with MI and LVEF\<40% will be evaluated, to know ICD implantation prevalence in such patients at Latin American countries * Stage 2 (Treatment): after patient screening and as per clinical decision, 962 patients will be entered in group 1 and 2 (481 each, 1:1) STEERING COMMITTEE * Dr. Sergio Dubner. Clinica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires - Argentina * Dr. William Uribe. CES CARDIOLOGIA. Medellin - Colombia CLINICAL ASSESSMENT • Dr Francisco Javier Alzueta Rodriguez. Hospital Clinico Universitario Virgen de la Victoria. Malaga - Spain REGISTRY DURATION * Patient enrollment period initiation: September 2011 * End of patient enrollment: September 2013 * End of FUs: September 2018 * Registry closure and data analyses: 4Q 2018. REGULATORY CONSIDERATIONS As this is an observational registry, no submission to National Authorities is required.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients that had Acute Myocardial Infarction (\>40 days post-AMI) documented with the presence of Q-wave or cardiac-specific enzymatic markers of myocardial necrosis (CK-MB/troponin), occurred within 3 years previous to enrollment / after June 2008.
Left Ventricular Ejection Fraction (LVEF) ≤40% post-revascularization (if no revascularization, measurement performed \<3 months previous to patient enrollment, \>40 days post-AMI and \>3 months post-revascularization -if applicable-).

Criterios de exclusión

Patient with an implanted ICD
\<18 years old
Pregnant or breast feeding women
Patients that are already participating in other Investigational Study or Registry
Non signed patient informed consent or refusal from patient's reference physician to patient participation
Patient inability to comply with protocol (assist to scheduled follow-ups), due to: residence displacement out of center's activity area; unstable geographical situation or at very long distance from the center; unstable medical and/or psychological condition
Cardiac transplanted (or in transplant waiting list)
Severe Heart Failure (or other co-morbidity: cancer, renal failure, etc.)
Life expectancy lower than 1 year

Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Implantable Cardio Defibrillator (ICD),

Ubicaciones

Centro Privado de Cardiologia

Patrocinadores