Hospital Mortality in Patients Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK)

Acute Coronary Syndrome Clinical Trial

Official title:

Hospital Mortality After ST Segment Elevation Acute Myocardial Infarction Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK): Analysis of 398 Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791764
• Other study ID #: SAMU-01
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: February 12, 2013
• Start date: November 2010
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Mortality		During hospital stay,an expected average of 15 days	No