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

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ClinicalTrials.gov Identifier: NCT02753023
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment
Acute Coronary Syndromes Heart Failure Pulmonary Edema Aortic Aneurysm, Familial Thoracic 1 Chest Pain Pulmonary Embolism Syncope 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1650 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Registry Of Acute meDical Emergencies in Brazil - ROAD-Brazil
Actual Study Start Date : May 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : May 2020

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




Primary Outcome Measures :
  1. mortality [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
emergency unit patients
Criteria

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.


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): NCT02753023


Locations
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Brazil
Pronto Socorro - Hospital Metropolitano Recruiting
Vitória, Espírito Santo, Brazil
Contact: Eduardo Al Roque, MD    + 55 (27) 2104 7056    edcastro77@gmail.com   
Unidade Coronariana do Hospital Estadual Mario Covas Recruiting
Santo André, São Paulo, Brazil
Contact: Caio Fernandes, MD    +55 (11) 98389-5884    drcaiofernandes@yahoo.com.br   
Hospital Unimed Sorocaba Recruiting
Sorocaba, São Paulo, Brazil
Contact: Fernando Figuinha, MD       fefigas@yahoo.com.br   
Instituto do Coração - HMFMUSP Recruiting
São Paulo, Brazil, 05403000
Contact: Alexandre Soeiro, MD    5511-2661-5299    alexandre.soeiro@bol.com.br   
Pronto Atendimento - Hospital Alemão Oswaldo Cruz Not yet recruiting
São Paulo, Brazil
Contact: Thiago Brito, MD    5511-98213-9363    thiagomidlej@gmail.com   
Pronto Socorro - Hospital TotalCor Recruiting
São Paulo, Brazil
Contact: Pedro Barros e Silva, MD    55 11 993151335    drpedrobarros80@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital

Additional Information:

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02753023     History of Changes
Other Study ID Numbers: PSInCor-ROAD-Brazil
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Chest Pain
Pain
Pulmonary Embolism
Pulmonary Edema
Syncope
Acute Coronary Syndrome
Embolism
Aortic Aneurysm
Emergencies
Heart Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Aneurysm
Vascular Diseases
Myocardial Ischemia
Embolism and Thrombosis
Aortic Diseases
Lung Diseases
Respiratory Tract Diseases
Neurologic Manifestations
Signs and Symptoms
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Nervous System Diseases