Status:
UNKNOWN
Fast Radial Pharmaco-invasive Strategy In ST Elevation Myocardial Infarction Trial
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
ST-segment Elevation Myocardial Infarction (STEMI)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
INTRODUCTION: The pharmaco-invasive strategy is a safe alternative to primary percutaneous coronary intervention (PCI) in patients with ST elevation acute myocardial infarction, who cannot be in the c...
Detailed Description
The FARAD MI will be a randomized, multicenter prospective study will be conducted. Patients with the diagnosis of ST-segment elevation acute myocardial infarction treated at the Sancta Maggiore Emerg...
Eligibility Criteria
Inclusion
- ST elevation myocardial infarction
- Submitted to thrombolysis
- Interventional Cardiology Department arrival less than 3 hours after the end of thrombolytic
Exclusion
- Fibrinolytic therapy contraindication: active internal bleeding, clinical signs of acute aortic dissection, traumatic or prolonged cardiopulmonary resuscitation (\> 10 minutes), head trauma in the last four weeks, history of intracranial neoplasia, ischemic stroke in the past year or previous haemorrhagic stroke, pregnancy, sustained severe hypertension (≥180 mmmHg systolic pressure and / or ≥110 mmHg diastolic pressure), trauma or major surgery in the last four weeks, use of oral anticoagulants, history of liver or kidney failure
- No reperfusion criteria when arriving at the Interventional Cardiology Department: no improvement in chest pain or reduction in ST-segment elevation below 50% after thrombolytic administration
- Femoral approach as the first choice for invasive stratification
- Bleeding complications before cardiac catheterization such as important hematoma and stroke
- Acute pulmonary edema: dyspnea of cardiac etiology with increased respiratory effort, hypoxemia and / or desaturation
- Cardiogenic shock: systolic blood pressure below 90 mmHg associated with signs of tissue hypoperfusion, such as oliguria, altered level of consciousness, cyanosis, cold and wet extremities, or vasopressor drug use
Key Trial Info
Start Date :
December 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04300582
Start Date
December 13 2019
End Date
August 31 2021
Last Update
March 31 2020
Active Locations (1)
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1
Sancta Maggiore Hospital
São Paulo, Brazil, 04506000