Clinical Registry on Sudden Death Primary Prevention at Latin America (ESCAPE-ICD)
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.
- 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).
|Myocardial Infarction Sudden Death||Procedure: Implantable Cardio Defibrillator (ICD),|
|Study Design:||Observational Model: Cohort|
|Official Title:||Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)|
- Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries [ Time Frame: Patients that suffered from MI in the last 3 years and during the enrollment period ]
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)
- Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring [ Time Frame: 5 years (until end 2018) ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Patients that receive an ICD implantation (non randomized, by clinical decision) will enter this group
Procedure: Implantable Cardio Defibrillator (ICD),
Standard ICD implantation (as per clinical decision)
Other Name: CE approved devices
Non ICD implantation
Patients that do not receive ICD implantation (non randomized, by clinical decision); they can receive any other treatment (e.g. antiarrhythmic drugs)
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)
- Dr. Sergio Dubner. Clinica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires - Argentina
- Dr. William Uribe. CES CARDIOLOGIA. Medellin - Colombia
• Dr Francisco Javier Alzueta Rodriguez. Hospital Clinico Universitario Virgen de la Victoria. Malaga - Spain
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422174
|Centro Privado de Cardiologia|
|Principal Investigator:||Sergio J Dubner, MD, FACC||Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, Argentina|
|Principal Investigator:||William Uribe, MD||CES Cardiología. Medellin, Colombia|
|Study Chair:||Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr||Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain|