Acute Coronary SyndromesROAD-BrazilNCT02753023
Registry Of Acute meDical Emergencies in Brazil
An observational study of Acute Coronary Syndromes and Heart Failure, run by University of Sao Paulo General Hospital at 6 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Coronary Syndromes, Heart Failure, Pulmonary Edema
- How many people
- 1,650 participants
- Where
- 6 sitesBrazil
- Study dates
- May 2015to May 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: emergency unit patients
Who may be able to join
- 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,
Show all 9Show fewer
- chest pain or,
- pulmonary embolism or
- syncope.
Who cannot join
- -There will be not exclusion criteria.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites, 6 recruiting
- Recruiting
Unidade Coronariana do Hospital Estadual Mario Covas
Santo André, São Paulo
Caio Fernandes, MD, +55 (11) 98389-5884, drcaiofernandes@yahoo.com.br
- Recruiting
Instituto do Coração - HMFMUSP
São Paulo, 05403000
Alexandre Soeiro, MD, 5511-2661-5299, alexandre.soeiro@bol.com.br
- Not yet recruiting
Pronto Atendimento - Hospital Alemão Oswaldo Cruz
São Paulo
Thiago Brito, MD, 5511-98213-9363, thiagomidlej@gmail.com
- Recruiting
Pronto Socorro - Hospital TotalCor
São Paulo
Pedro Barros e Silva, MD, 55 11 993151335, drpedrobarros80@gmail.com
- Recruiting
Hospital Unimed Sorocaba
Sorocaba, São Paulo
Fernando Figuinha, MD, fefigas@yahoo.com.br
- Recruiting
Pronto Socorro - Hospital Metropolitano
Vitória, Espírito Santo
Eduardo Al Roque, MD, + 55 (27) 2104 7056, edcastro77@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndromes, Heart Failure, Pulmonary Edema, Aortic Aneurysm, Familial Thoracic 1, Chest Pain, Pulmonary Embolism
- Being tested
- no intervention
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure, Pulmonary Edema, Aortic Aneurysm, Familial Thoracic 1, Chest Pain, Pulmonary Embolism, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
No intervention related
| Study group | Role | What they receive |
|---|---|---|
| acute coronary syndromes | No intervention related Receives: Other: no intervention | |
| acute decompensated heart failure | No intervention related Receives: Other: no intervention | |
| warfarin intoxication | No intervention related Receives: Other: no intervention | |
| acute pulmonary edema | No intervention related Receives: Other: no intervention | |
| acute aortic dissection | No intervention related Receives: Other: no intervention | |
| chest pain | No intervention related Receives: Other: no intervention | |
| pulmonary embolism | No intervention related Receives: Other: no intervention | |
| syncope | No intervention related Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 6 months
Secondary outcomes (1)
mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionJan 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,650 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753023
- Sponsor's protocol ID
- PSInCor-ROAD-Brazil
- Acronym
- ROAD-Brazil
- Status last verified
- Oct 2018
- First submitted
- 26 Apr 2016
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Silva PGMBE, Soeiro AM, Balada R, Macedo L, Lacerda MDV, Correia LVA, Ximenes MC, Dias KT, Moura SC, Catellani SGG, Lopes RD. Clinical profile of acute myocardial infarction: the Registry of Acute Medical Emergencies registry. Rev Assoc Med Bras (1992). 2026 Aug 10;72(6):e20251775. doi: 10.1590/1806-9282.20251775. eCollection 2026.
PubMed 42585422
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Of Acute meDical Emergencies in Brazil - ROAD-Brazil
- ClinicalTrials.gov ID
- NCT02753023
- Acronym / sponsor ID
- ROAD-Brazil / PSInCor-ROAD-Brazil
- Conditions
- Acute Coronary Syndromes, Heart Failure, Pulmonary Edema, Aortic Aneurysm, Familial Thoracic 1, Chest Pain, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| acute coronary syndromes | – | Other: no interventionNo intervention related |
| acute decompensated heart failure | – | Other: no interventionNo intervention related |
| warfarin intoxication | – | Other: no interventionNo intervention related |
| acute pulmonary edema | – | Other: no interventionNo intervention related |
| acute aortic dissection | – | Other: no interventionNo intervention related |
| chest pain | – | Other: no interventionNo intervention related |
| pulmonary embolism | – | Other: no interventionNo intervention related |
| syncope | – | Other: no interventionNo intervention related |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- emergency unit patients
Key inclusion criteria (9 listed)
- all patients with:
- acute coronary syndromes (ACS) or,
- acute decompensated heart failure (ADHF) or,
- warfarin intoxication or,
- acute pulmonary edema or,
Key exclusion criteria (1 listed)
- -There will be not exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionNo intervention related | Other | acute aortic dissection, acute coronary syndromes, acute decompensated heart failure, acute pulmonary edema, chest pain, pulmonary embolism, syncope, warfarin intoxication |
Primary outcome
mortality
Time frame: 6 months
1 secondary outcome
mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Derived from this study: PubMed 42585422Silva PGMBE, Soeiro AM, Balada R, Macedo L, Lacerda MDV, Correia LVA, Ximenes MC, Dias KT, Moura SC, Catellani SGG, Lopes RD. Clinical profile of acute myocardial infarction: the Registry of Acute Medical Emergencies registry. Rev Assoc Med Bras (1992). 2026 Aug 10;72(6):e20251775. doi: 10.1590/1806-9282.20251775. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Unidade Coronariana do Hospital Estadual Mario Covas
Santo André, Brazil
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes and Heart Failure, run by University of Sao Paulo General Hospital at 6 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.