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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01791764
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Felipe José de Andrade Falcão, Federal University of São Paulo
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Days
Official Title: Hospital Mortality After ST Segment Elevation Acute Myocardial Infarction Submitted to Pharmacoinvasive Strategy With Tenecteplase (TNK): Analysis of 398 Patients.

Resource links provided by NLM:


Further study details as provided by Felipe José de Andrade Falcão, Federal University of São Paulo:

Primary Outcome Measures:
  • Hospital Mortality [ Time Frame: During hospital stay,an expected average of 15 days ]

Enrollment: 368
Study Start Date: November 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients will be selected from primary care clinic.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791764


Locations
Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Felipe JA Falcao Federal University of Sao Paulo
Principal Investigator: Claudia MR Alves, Doctor Federal University of Sao Paulo
Study Director: Antonio CC Carvalho Federal University of Sao Paulo
Study Director: Adriano HP Barbosa Federal University of Sao Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felipe José de Andrade Falcão, Master, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01791764     History of Changes
Other Study ID Numbers: SAMU-01
First Submitted: February 8, 2013
First Posted: February 15, 2013
Last Update Posted: February 15, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action