Clinical Registry on Sudden Death Primary Prevention at Latin America (ESCAPE-ICD)

This study is currently recruiting participants.
Verified September 2012 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01422174
First received: August 18, 2011
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention
Myocardial Infarction
Sudden Death
Procedure: Implantable Cardio Defibrillator (ICD),

Study Type: Observational
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)

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • Study incidence of Arrhythmic mortality and serious arrhythmic events, evaluated through remote monitoring [ Time Frame: 5 years (until end 2018) ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: March 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICD implantation
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)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422174

Contacts
Contact: Sonia M Martín +34 917991213 sonia.martin@biotronik.es

Locations
Argentina
Centro Privado de Cardiologia Recruiting
Tucuman, Argentina
Contact: Aguinaga, Dr         
Principal Investigator: Luis E Aguinaga, Dr         
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
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
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01422174     History of Changes
Other Study ID Numbers: TA098
Study First Received: August 18, 2011
Last Updated: September 24, 2012
Health Authority: Argentina: Institute for Clinical Effectiveness and Health Policy
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Brazil: National Committee of Ethics in Research

Keywords provided by Biotronik SE & Co. KG:
Primary prevention
Latin America
Sudden death
Myocardial infarction
Ejection Fraction
ICD

Additional relevant MeSH terms:
Death
Death, Sudden
Infarction
Myocardial Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014