Clinical Registry on Sudden Death Primary Prevention at Latin America

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Myocardial Infarction, Sudden Death

Intervention / Treatment
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* Procedure: Implantable Cardio Defibrillator (ICD),


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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-). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICD implantation<br>Patients that receive an ICD implantation (non randomized, by clinical decision) will enter this group | Procedure: Implantable Cardio Defibrillator (ICD),<br>* Standard ICD implantation (as per clinical decision)<br>* Other names: CE approved devices;|
| Non ICD implantation<br>Patients that do not receive ICD implantation (non randomized, by clinical decision); they can receive any other treatment (e.g. antiarrhythmic drugs) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries | Primary Outcome at Stage 1: Determine prevalence of patients with myocardial infarction and high risk of sudden death at Latin America, that fulfill inclusion criteria Primary Outcome at Stage 2: Compare MACE development in patients that receive ICD implantation vs patients that receive other type of treatment (non ICD) | Patients that suffered from MI in the last 3 years and during the enrollment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring |  | 5 years (until end 2018) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary prevention, Latin America, Sudden death, Myocardial infarction, Ejection Fraction, ICD