Clinical trial NCT01791764: Hospital Mortality in Patients Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK)
Official title: Hospital Mortality After ST Segment Elevation Acute Myocardial Infarction Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK): Analysis of 398 Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be selected from primary care clinic.

Brief summary: This study has the following objective:

To identify related factors to hospital mortality in patients with ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy within a structured healthcare network.

Detailed description: Primary percutaneous coronary intervention is the main therapy for patients with ST-segment elevation acute myocardial infarction. However, a significant portion of these patients won't receive optimal treatment due to the small number of tertiary centers with interventional laboratories available for 24 hours a day, 7 days a week.

Specially in large urban centers and rural areas, where tertiary care hospitals are restricted to a specific region, alternative approaches must be developed. The pharmacoinvasive strategy has emerged as an alternative for patients admitted to primary care centers. It is based in up-front intravenous thrombolytic therapy and transfer to a tertiary center where early, systematic, coronary intervention will be performed between 3 to 24 hours after the administration of thrombolytic drugs, even in cases in which successful reperfusion was obtained.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ST-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy with tenecteplase.

Exclusion Criteria:

* Absence of obstructive coronary disease
* Surgical reference
* Did not undergo catheterization

Primary outcomes:
measure: Hospital Mortality
timeFrame: During hospital stay,an expected average of 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Felipe JA Falcao
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Claudia MR Alves, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Antonio CC Carvalho
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Adriano HP Barbosa
role: STUDY_DIRECTOR
References:
citation: Falcao FJ, Alves CM, Barbosa AH, Caixeta A, Sousa JM, Souza JA, Amaral A, Wilke LC, Perez FC, Goncalves Junior I, Stefanini E, Carvalho AC. Predictors of in-hospital mortality in patients with ST-segment elevation myocardial infarction undergoing pharmacoinvasive treatment. Clinics (Sao Paulo). 2013 Dec;68(12):1516-20. doi: 10.6061/clinics/2013(12)07.