Registry Of Acute meDical Emergencies in Brazil (ROAD-Brazil)

Registry Of Acute meDical Emergencies in Brazil - ROAD-Brazil

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Chest Pain; Syncope; Pulmonary Embolism; Pulmonary Edema; Acute Coronary Syndromes; Aortic Aneurysm, Familial Thoracic 1
• Intervention / Treatment: Other: no intervention

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 Type: Observational
• Enrollment (Anticipated): 1650

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403000
    • Recruiting
    • Instituto do Coração - HMFMUSP
  • São Paulo, Brazil
    • Not yet recruiting
    • Pronto Atendimento - Hospital Alemão Oswaldo Cruz
    • Contact: Thiago Brito, MD; Phone Number: 5511-98213-9363; Email: thiagomidlej@gmail.com
  • São Paulo, Brazil
    • Recruiting
    • Pronto Socorro - Hospital TotalCor
    • Contact: Pedro Barros e Silva, MD; Phone Number: 55 11 993151335; Email: drpedrobarros80@gmail.com
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil
      • Recruiting
      • Pronto Socorro - Hospital Metropolitano
      • Contact: Eduardo Al Roque, MD; Phone Number: + 55 (27) 2104 7056; Email: edcastro77@gmail.com
  • São Paulo
    • Santo André, São Paulo, Brazil
      • Recruiting
      • Unidade Coronariana do Hospital Estadual Mario Covas
      • Contact: Caio Fernandes, MD; Phone Number: +55 (11) 98389-5884; Email: drcaiofernandes@yahoo.com.br
    • Sorocaba, São Paulo, Brazil
      • Recruiting
      • Hospital Unimed Sorocaba
      • Contact: Fernando Figuinha, MD; Email: fefigas@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

emergency unit patients

Description

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
• syncope.

Exclusion Criteria:

-There will be not exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
acute coronary syndromes; No intervention related	Other: no intervention; No intervention related
acute decompensated heart failure; No intervention related	Other: no intervention; No intervention related
warfarin intoxication; No intervention related	Other: no intervention; No intervention related
acute pulmonary edema; No intervention related	Other: no intervention; No intervention related
acute aortic dissection; No intervention related	Other: no intervention; No intervention related
chest pain; No intervention related	Other: no intervention; No intervention related
pulmonary embolism; No intervention related	Other: no intervention; No intervention related
syncope; No intervention related	Other: no intervention; No intervention related

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	12 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 26, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Lung Diseases; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Embolism and Thrombosis; Unconsciousness; Consciousness Disorders; Aortic Diseases; Emergencies; Embolism; Chest Pain; Acute Coronary Syndrome; Syncope; Aneurysm; Pulmonary Embolism; Aortic Aneurysm; Pulmonary Edema
• Other Study ID Numbers: PSInCor-ROAD-Brazil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO