Clinical Registry on Sudden Death Primary Prevention at Latin America

NCT ID: NCT01422174

Last Updated: 2015-03-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-01-31

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.

Conditions

Myocardial Infarction; Sudden Death

Study Design

• Observational Model Type: COHORT

Study Groups

ICD implantation

Patients that receive an ICD implantation (non randomized, by clinical decision) will enter this group

Implantable Cardio Defibrillator (ICD),

Intervention Type: PROCEDURE

Standard ICD implantation (as per clinical decision)

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)

No interventions assigned to this group

Interventions

Implantable Cardio Defibrillator (ICD),

Standard ICD implantation (as per clinical decision)

Intervention Type: PROCEDURE

Other Intervention Names

CE approved devices

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergio J Dubner, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

Clínica y Maternidad Suizo Argentina and De Los Arcos Sanatorio. Buenos Aires, Argentina

William Uribe, MD

Role: PRINCIPAL_INVESTIGATOR

CES Cardiología. Medellin, Colombia

Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr

Role: STUDY_CHAIR

Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain

Locations

Centro Privado de Cardiologia

San Miguel de Tucumán, Tucumán Province, Argentina

Countries

Argentina

Other Identifiers

TA098

Identifier Type: -

Identifier Source: org_study_id