Clinical Registry on Sudden Death Primary Prevention at Latin America

NCT01422174 | Withdrawn

• 1 other identifier: TA098
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Myocardial Infarction; Sudden Death

Keywords

Primary prevention; Latin America; Sudden death; Myocardial infarction; Ejection Fraction; ICD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring

  5 years (until end 2018)

Study Arms (2)

ICD implantation

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

Procedure: Implantable Cardio Defibrillator (ICD),

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)

Interventions

Implantable Cardio Defibrillator (ICD), PROCEDURE

Standard ICD implantation (as per clinical decision)

Also known as: CE approved devices

ICD implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at Latin American countries that fulfill MADIT, MADIT II and/or MUSTT criteria.

You may qualify if:

• 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-).

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (1)

Centro Privado de Cardiologia

San Miguel de Tucumán, Tucumán Province, Argentina

Location

MeSH Terms

Conditions

Myocardial Infarction; Death, Sudden

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Death

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Francisco J Alzueta Rodriguez (Study Clinical Advisor), Dr

  Hospital Clínico Universitario Virgen de la Victoria. Málaga, Spain

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 23, 2011
• Study Start: March 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 3, 2015

Record last verified: 2015-03

Locations

AR (1)