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Sao Paulo ST Segment Elevation Myocardial Infarction (STEMI) Registry

NCT02090712 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2023-01-17

No results posted yet for this study

Summary

At the periphery of the city of São Paulo, in-hospital mortality in acute myocardial infarction is estimated to range between 15% and 20% due to difficulties inherent to delayed answer at a large metropolis. As a city with more than 11 million inhabitants, the distribution of emergency services and public hospitals is also heterogeneous, with scarcity in peripheral zones. That heterogeneity of resources also involves the quality of the medical care provided. The possibility of a standard care with fast transfer after thrombolysis and a tertiary backing system for ECG interpretation, catheterization and advanced support could improve this setting.

In a project initiated in 2010, the São Paulo Municipal Health Secretariat, the Federal University of Sao Paulo/Paulista School of Medicine, the Emergency Mobile Health Care Service arranged a planed system of thrombolysis at peripheral hospitals or at the ambulances with immediate transfer to a unique tertiary center for early angiography and angioplasty of the culprit artery. The protocol uses recommendations of Brazilian and international guidelines, and is the same adopted for the management of ST elevation myocardial infarction at Paulista School of Medicine regarding the indications for thrombolytic agents, primary and rescue percutaneous transluminal coronary angioplasty (PTCA), and pharmacoinvasive therapy.

The hypothesis of this study is that a network to provide the best care for patients with ST elevation myocardial infarction will reduce mortality rates.

The main purpose of this registry is to provide demographics, metrics and results of this experience, maintaining complete records of clinical, laboratory and coronary angiography data of all patients allowing short-term outcome analysis of various variables in a large population. Additionally, follow-up outcomes will be provide in a sub-group of patients keeping their health care at the University or able to be tracked.

All clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation at different time intervals.

Conditions

Interventions

PROCEDURE

PCI

Balloon dilatation of the culprit artery followed by stent implantation will be made immediately for patients not receiving thrombolysis or after 3 to 24 hours after thrombolysis, under clinical indication and current practice patterns, in the setting of acute myocardial infarction

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Iran Gonçalves Jr, m.d., Phd · Assistant professor

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2019-12-31
Completion
2023-09-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02090712 on ClinicalTrials.gov