ACS - Acute Coronary SyndromeBRAvAdONCT04222608
The BRAvAdO Registry
An observational study of ACS - Acute Coronary Syndrome and Oncology, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The BRAVADO Registry pretends to identify stratification, diagnosis, total atherosclerotic burden and treatment approaches in oncologic patients with Acute Coronary Syndrome (ACS) and identify strategies to improve health care quality Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACS - Acute Coronary Syndrome, Oncology
- How many people
- 600 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2016to 1 Sep 2021
- How long will I take part?
- 4 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with Acute Coronary Syndrome (ACS)
Who may be able to join
- Definitive cancer diagnosis - biopsy
- Acute Coronary Syndrome - requiring urgent invasive risk stratification
Who cannot join
- KPS < 60 , ECOG >/ 3
- Life expectancy less 24hs
- End of Life Care
- Lack of consistent record data
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Carlos M Campos
São Paulo, 05403-900
CARLOS M CAMPOS, PhD, +55 11 2661 5286, carlosacampos1@gmail.com
Ludhmila A Hajjar, Prof
About this study
Official title: BRAzilian Registry of Acute Coronary Syndrome in Oncologic Patients - The BRAvAdO Registry
The BRAVADO Registry pretends to identify stratification, diagnosis, total atherosclerotic burden and treatment approaches in oncologic patients with Acute Coronary Syndrome (ACS) and identify strategies to improve health care quality
- Conditions
- ACS - Acute Coronary Syndrome, Oncology
- Keywords
- Cardio-Oncology, Interventional Cardiology, Cancer, Oncology, Acute Coronary Syndrome, Myocardial Infarction
- Medical subject headings
- Acute Coronary Syndrome, Neoplasms, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Composite endpoint of All-cause Death, Myocardial Infarction, Stroke and Myocardial Revascularization
Measured: 30 days
Total Atherosclerotic burden and lesion complexity on angiography
The number and location of coronary lesions with obstructions greater than 50% were recorded. Each lesion was classified based on Ambrose's, Goldstein complexity, Leaman and SYNTAX scores.
Measured: 30 days
Incidence of Major Bleeding
Requiring a transfusion of ≥2 U PRBCs Resulting in a decrease in hematocrit of ≥10% Occurring intracerebrally Resulting in stroke or death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Sep 2016
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (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 ACS - Acute Coronary SyndromeStudies of the same condition, open and under way.
- 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
- 600 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto do Cancer do Estado de São Paulo, Beneficência Portuguesa de São Paulo, Instituto de Cardiologia do Rio Grande do Sul, InCor Heart Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222608
- Sponsor's protocol ID
- BRAvAdO
- Acronym
- BRAvAdO
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seleme VB, da Silva Costa IBS, Pileggi B, de Barros Branco CE, Rizk SI, de Medeiros Lopes MAAA, Campanha Borges DC, Campos RN, de Brito FS, Abdalla Sanches JM, Godinho RR, Esper RB, Faillace B, Precoma DB, Ribeiro MH, Seabra-Garcez JD, Nunes Ferreira AF, Kalil Filho R, Abizaid A, Hajjar LA, Campos CM. Association of cancer on coronary atherosclerotic burden and plaque rupture: Insights from the BRAVADO study. Atherosclerosis. 2026 Apr;415:120683. doi: 10.1016/j.atherosclerosis.2026.120683. Epub 2026 Feb 19.
PubMed 41763067
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAzilian Registry of Acute Coronary Syndrome in Oncologic Patients - The BRAvAdO Registry
- ClinicalTrials.gov ID
- NCT04222608
- Acronym / sponsor ID
- BRAvAdO / BRAvAdO
- Conditions
- ACS - Acute Coronary Syndrome, Oncology
- Keywords
- Cardio-Oncology, Interventional Cardiology, Cancer, Oncology, Acute Coronary Syndrome, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto do Cancer do Estado de São Paulo, Beneficência Portuguesa de São Paulo, Instituto de Cardiologia do Rio Grande do Sul, InCor Heart Institute
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 10 Jan 2020 (actual)
- 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.
The BRAVADO Registry pretends to identify stratification, diagnosis, total atherosclerotic burden and treatment approaches in oncologic patients with Acute Coronary Syndrome (ACS) and identify strategies to improve health care quality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with Acute Coronary Syndrome (ACS)
Key inclusion criteria (2 listed)
- Definitive cancer diagnosis - biopsy
- Acute Coronary Syndrome - requiring urgent invasive risk stratification
Key exclusion criteria (4 listed)
- KPS < 60 , ECOG >/ 3
- Life expectancy less 24hs
- End of Life Care
- Lack of consistent record data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular events
Time frame: 30 days
Composite endpoint of All-cause Death, Myocardial Infarction, Stroke and Myocardial Revascularization
Total Atherosclerotic burden and lesion complexity on angiography
Time frame: 30 days
The number and location of coronary lesions with obstructions greater than 50% were recorded. Each lesion was classified based on Ambrose's, Goldstein complexity, Leaman and SYNTAX scores.
Incidence of Major Bleeding
Time frame: 30 days
Requiring a transfusion of ≥2 U PRBCs Resulting in a decrease in hematocrit of ≥10% Occurring intracerebrally Resulting in stroke or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Derived from this study: PubMed 41763067Seleme VB, da Silva Costa IBS, Pileggi B, de Barros Branco CE, Rizk SI, de Medeiros Lopes MAAA, Campanha Borges DC, Campos RN, de Brito FS, Abdalla Sanches JM, Godinho RR, Esper RB, Faillace B, Precoma DB, Ribeiro MH, Seabra-Garcez JD, Nunes Ferreira AF, Kalil Filho R, Abizaid A, Hajjar LA, Campos CM. Association of cancer on coronary atherosclerotic burden and plaque rupture: Insights from the BRAVADO study. Atherosclerosis. 2026 Apr;415:120683. doi: 10.1016/j.atherosclerosis.2026.120683. Epub 2026 Feb 19.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS - Acute Coronary Syndrome and Oncology, run by University of Sao Paulo General Hospital at 1 site 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 2 inclusion and 4 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 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Major adverse cardiovascular events (time frame: 30 days). The study lists 3 primary outcomes in all. 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 NCT04222608, 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 10 Jan 2020.