Clinical trial NCT01422174: Clinical Registry on Sudden Death Primary Prevention at Latin America
Official title: Clinical Registry on Sudden Death Primary Prevention at Latin America (rEgiStro Clinico en America Latina de Prevencion Primaria en muErte Subita)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Myocardial Infarction
Sudden Death
Keywords: Primary prevention
Latin America
Sudden death
Myocardial infarction
Ejection Fraction
ICD
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2011-08-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at Latin American countries that fulfill MADIT, MADIT II and/or MUSTT criteria.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of patients with MADIT, MADIT II and MUST at Latin American countries
timeFrame: Patients that suffered from MI in the last 3 years and during the enrollment period
Secondary outcomes:
measure: Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring
timeFrame: 5 years (until end 2018)
Other outcomes:
Locations:
city: Tucuman
country: Argentina
facility: Centro Privado de Cardiologia
Study officials:
affiliation: Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, Argentina
name: Sergio J Dubner, MD, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: CES Cardiología. Medellin, Colombia
name: William Uribe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain
name: Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr
role: STUDY_CHAIR
References: