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Clinical Trials/NCT02753023
NCT02753023UnknownNot Applicable

Registry Of Acute meDical Emergencies in Brazil - ROAD-Brazil

University of Sao Paulo General Hospital6 sites in 1 country1,650 target enrollmentStarted: May 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
1,650
Locations
6
Primary Endpoint
mortality

Study Overview

Brief Summary

Critical patients in emergency room are seriously situations that need quickly diagnosis and treatment. Different predictors of prognosis can be related with mortality and morbidity in-hospital and in long-term. In Brazil, this kind of registry is not available. The aim of the study is analysis and report data about critical patients in Emergency Departments over all country, showing demographic, clinical and prognosis data about that in Brazil.

Detailed Description

This will be a prospective and multicentric data-bank registry. Initially, all patients with acute coronary syndromes (ACS), acute decompensated heart failure (ADHF), warfarin intoxication, acute pulmonary edema, acute aortic dissection, chest pain, pulmonary embolism and syncope will be included. There will be not exclusion criteria. The inclusion criteria will be followed by definition of each illness described in recent guidelines. Investigators estimated annually over than 500 cases with ACS/chest pain, 300 cases of ADHF, 200 cases of aortic dissection, 200 of pulmonary embolism, 200 cases of warfarin intoxication, 100 cases of syncope and 150 of acute pulmonary edema. Clinical data, electrocardiographic and echocardiographic findings, laboratory results and prognosis will be related. Routine of treatment will be defined by each center. The analysis includes minimum, medium and maximum values. Variables will be adjusted according with each diagnosis and all data will be included using the REDCap digital data entry. Probabilities will be determined by logistic regression and will be considered significate when p < 0.005. Prospectively, investigators will use the Cox model to calculate associations.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • all patients with:
  • acute coronary syndromes (ACS) or,
  • acute decompensated heart failure (ADHF) or,
  • warfarin intoxication or,
  • acute pulmonary edema or,
  • acute aortic dissection or,
  • chest pain or,
  • pulmonary embolism or

Exclusion Criteria

  • There will be not exclusion criteria.

Outcomes

Primary Outcomes

mortality

Time Frame: 6 months

Secondary Outcomes

  • mortality(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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