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CABG-patientsBRASCORE CABGNCT07293533

Brazilian System for Cardiac Operative Risk Evaluation CABG

An observational study of CABG-patients, run by University of Sao Paulo General Hospital at 5 sites in Brazil.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Grouping relevant demographic and clinical information at specific stratified levels, and in correlation with the required resource sets, represents the possibility to adapt, improve, and innovate in cardiac surgery programs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CABG-patients
How many people
2,400 participants
Where
5 sitesBrazil
Study dates
1 Apr 2024to 30 Jul 2026
How long will I take part?
30 Days
Phase
Observational
Are there results?
Not yet: the study is under way

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: The study population will consist of all consecutive patients undergoing isolated CABG at the participating centers during the study period.

Who may be able to join

  • Patients submitted to isolated coronary artery bypass grafting at participating centers

Who cannot join

  • Emergency or salvage CABG procedures.
  • Associated procedures (e.g., valve surgery, aortic surgery).
  • Missing mandatory data in the registry.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

Brazil5 sites

  • Hospital de Messejana

    Fortaleza, Ceará

  • Hospital Alberto Urquiza Wanderley

    João Pessoa, Paraíba, 58040-300

  • Instituto Nacional de Cardiologia de Laranjeiras

    Rio de Janeiro, 22240-002

  • USP Heart Institute

    São Paulo, São Paulo, 05403-900

  • Beneficência Portuguesa de São Paulo

    São Paulo, 01323-001

Other trials in Brazil

About this study

Official title: Estratificação de Risco em Cirurgia de revascularização miocárdica no Brasil: CABG - BraSCORE (Brazilian System for Cardiac Operative Risk Evaluation)

Grouping relevant demographic and clinical information at specific stratified levels, and in correlation with the required resource sets, represents the possibility to adapt, improve, and innovate in cardiac surgery programs. In this path, the pursuit of implementing large databases for continuous improvement cycles becomes the foundation of the entire process. In Brazil, where structural and socioeconomic differences are significant, the standardization and sustainability of a large database become a major challenge. Projects like REPLICCAR (São Paulo Cardiovascular Surgery Registry) and BYPASS Registry, which were created to identify improvement opportunities, were temporary. The absence of a continuous multicenter registry makes it difficult to understand risk-adjusted patient outcomes and to implement cost-effective quality initiatives. For example, in 2022, the Ministry of Health launched the QualiSUS Cardio program, which began to consider hospital reimbursement not only in terms of surgical volume but also in relation to mortality, length of stay, and readmission rates after cardiac surgery. Changes like this already occur in various scenarios where payers, whether public or private, seek reimbursement through value-based models. However, for this to happen, the results need to be adjusted to patient risk. Otherwise, hospitals treating more severe patients would be at a disadvantage. This study aims to develop CABG-BraSCORE, a risk score to stratify patients referred for CABG surgery, adjusting outcomes to patient risk, and seeking continuous improvement for cardiac surgery programs in Brazil.

Read the detailed description

Study Procedure: Data collection will be conducted from patient records, including demographic characteristics, preoperative status, surgical and postoperative data of CABG surgery, and follow-up up to 30 days post-discharge.

Centers with prospective data collection: Participants will be contacted 30 days after surgery and invited to participate in the study. The Free and Informed Consent Form (FICF) will be applied via telephone (Appendix 1). All FICF sessions will be recorded, downloaded, and stored according to the established study protocols.

Centers with retrospective data collection: Thirty days after surgery, it should be recorded whether there was a return visit to the outpatient clinic, readmission to the institution, the reason for readmission, such as surgical complications, stroke, surgical wound infection, myocardial infarction, and mortality at 30 days. All records should be consulted in the patient's medical record. If there is no information recorded about the patient's return visit, loss to follow-up should be considered. A loss of 20% was considered for the sample composition.

After the telephone FICF, a questionnaire (Appendix 2, within the Cardux platform's "Post-discharge Events" section) will be applied to gather information regarding readmissions, death, adverse events, among others, within 30 days after hospital discharge.

Patient data will be entered into the Cardux platform according to study protocol variables.

All inclusion steps will be guided by the coordinating center, providing clarification about the study protocol and ensuring its compliance, respecting the ethical and legal principles of the study.

  • Risks to Participants Participants will be exposed to minimal risk as this study will not involve interventions, only a single telephone interview. Therefore, no risks to participants are anticipated, as the data collection will be entirely retrospective and the consent forms will be stored confidentially.
  • Benefits to Participants: Participants will not receive any direct benefit from participating in this study. However, in the future, they might benefit from improved risk stratification for CABG surgeries, contributing to enhanced patient care and resource allocation.
  • Cardux Platform Cardux platform will be used for data management and analysis. This platform facilitates real-time monitoring and auditing of data, ensuring consistency and accuracy. The platform also supports predictive modeling and quality assessment.
  • Quality Audit of Records: To ensure data quality, a series of audits will be conducted. These audits will involve checking data completeness, consistency, and accuracy. Discrepancies will be resolved through communication with the participating centers.
  • Data analysis will include statistical methods to evaluate risk factors and develop the BraSCORE. The model's performance will be validated and compared with existing international risk scores (EuroSCORE III and STS)
  • Development of Machine Learning Algorithms Machine learning algorithms will be employed to develop predictive models for hospital mortality, readmission risk, and prolonged hospitalization.
Conditions
CABG-patients
Keywords
Databases, Database Management Systems, Coronary Artery Bypass, Predictions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality

    death occurring at any point during the hospitalization for surgery, even if after 30 days

    Measured: up to 3 months during hospital admission for CABG

  2. 30-day mortality

    death occurring after discharge from the hospital, but within 30-days of the procedure

    Measured: 30-days of the procedure

Secondary outcomes (2)

  1. Prolonged Hospital Stay

    Postoperative hospital stay longer than 14 days, excluding in-hospital deaths

    Measured: postoperative hospital stay longer than 14 days

  2. 30-day readmission

    any unplanned admission for any reason within 30-days of CABG surgery discharge

    Measured: 30-days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start1 Apr 2024
  3. Primary completion1 May 2026 (estimated)
  4. Study completion30 Jul 2026 (estimated)

Resources

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
Other
Enrolment
2,400 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07293533
Sponsor's protocol ID
76508623.2.1001.0068
Other IDs
7.933.450
Acronym
BRASCORE CABG
Status last verified
Dec 2025
First submitted
25 Nov 2025
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The Individual Participant Data (IPD) that support the findings of this study are not publicly available due to ethical restrictions imposed by the participating centers and the overseeing ethics committee (Comissão de Ética para Análise de Projetos de Pesquisa - CAPPesq). However, de-identified data may be made available to qualified researchers upon reasonable request, subject to approval by CAPPesq and the execution of a data sharing agreement.

Publications

  • Atik FA. Registries and Evidence-Based Medicine. Arq Bras Cardiol. 2024 Aug 2;121(6):e20240330. doi: 10.36660/abc.20240330. eCollection 2024. No abstract available. English, Portuguese.

    PubMed 39109690

Questions about this trial

What is this clinical trial studying?

An observational study of CABG-patients, run by University of Sao Paulo General Hospital at 5 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 1 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital mortality (time frame: up to 3 months during hospital admission for CABG). The study lists 2 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 NCT07293533, 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 19 Dec 2025.

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