Registry Of Acute meDical Emergencies in Brazil

Heart Failure Clinical Trial

— ROAD-Brazil  

Official title:

Registry Of Acute meDical Emergencies in Brazil - ROAD-Brazil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753023
• Other study ID #: PSInCor-ROAD-Brazil
• Status: Recruiting
• Start date: May 2015
• Est. completion date: May 2020

Study information

• Verified date: October 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1650
• Est. completion date: May 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Familial Thoracic 1
• Aortic Aneurysm, Thoracic
• Chest Pain
• Embolism
• Emergencies
• Heart Failure
• Pulmonary Edema
• Pulmonary Embolism
• Syncope

Intervention

Other:
• no intervention
No intervention related

Locations

Country	Name	City	State
Brazil	Unidade Coronariana do Hospital Estadual Mario Covas	Santo André	São Paulo
Brazil	Instituto do Coração - HMFMUSP	São Paulo
Brazil	Pronto Atendimento - Hospital Alemão Oswaldo Cruz	São Paulo
Brazil	Pronto Socorro - Hospital TotalCor	São Paulo
Brazil	Hospital Unimed Sorocaba	Sorocaba	São Paulo
Brazil	Pronto Socorro - Hospital Metropolitano	Vitória	Espírito Santo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		6 months
Secondary	mortality		12 months