Myocardial Infarction | Clinical Registry on Sudden Death Primary Prevention at Latin America
Myocardial Infarction research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Implantable Cardio Defibrillator (ICD),Standard ICD implantation (as per clinical decision)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ICD implantationPatients that receive an ICD implantation (non randomized, by clinical decision) will enter this group
Non ICD implantationPatients that do not receive ICD implantation (non randomized, by clinical decision); they can receive any other treatment (e.g. antiarrhythmic drugs)
Start Date: March 2012
Completed Date: January 2015
Primary Outcome: Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries
Secondary Outcome: Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring
Study sponsors, principal investigator, and references
Principal Investigator: Sergio J Dubner, MD, FACC