Status:
WITHDRAWN
Clinical Registry on Sudden Death Primary Prevention at Latin America
Lead Sponsor:
Biotronik SE & Co. KG
Conditions:
Myocardial Infarction
Sudden Death
Eligibility:
All Genders
18+ years
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...
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 count...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01422174
Start Date
March 1 2012
End Date
January 1 2015
Last Update
March 3 2015
Active Locations (1)
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1
Centro Privado de Cardiologia
San Miguel de Tucumán, Tucumán Province, Argentina