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Brazilian System for Cardiac Operative Risk Evaluation CABG

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07293533
Acronym
BRASCORE CABG
Enrollment
2400
Registered
2025-12-19
Start date
2024-04-01
Completion date
2026-07-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CABG-patients

Keywords

Databases, Database Management Systems, Coronary Artery Bypass, Predictions

Brief 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. 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.

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.

Interventions

None listed

Sponsors

Instituto Nacional de Cardiologia de Laranjeiras
CollaboratorOTHER
Beneficência Portuguesa de São Paulo
CollaboratorOTHER
Santa Casa de Misericórdia de Marília
CollaboratorUNKNOWN
Professor Fernando Figueira Integral Medicine Institute
CollaboratorOTHER
Hospital do Coração de Messejana Dr. Carlos Alberto Studart
CollaboratorUNKNOWN
Instituto de Cardiologia do Rio Grande do Sul
CollaboratorOTHER
Irmandade da Santa Casa de Misericordia de Curitiba
CollaboratorOTHER
Hospital Universitário do Maranhão - MA
CollaboratorUNKNOWN
Hospital do Coração Alagoano Prof. Adib Jatene
CollaboratorUNKNOWN
Irmandade da Santa Casa de Misericordia de Sao Paulo
CollaboratorOTHER
Hospital São Francisco de Assis na Providência de Deus - RJ
CollaboratorUNKNOWN
Hospital Universitario Pedro Ernesto
CollaboratorOTHER
Cardiac Emergency Hospital of Pernambuco
CollaboratorUNKNOWN
Hospital Geral de Cuiabá
CollaboratorUNKNOWN
Hospital Beneficente Portuguesa de Belém
CollaboratorUNKNOWN
Pronto-Socorro Cardiológico Universitário de Pernambuco
CollaboratorUNKNOWN
Hospital Alberto Urquiza Wanderley de João Pessoa
CollaboratorUNKNOWN
Hospital e Maternidade Marieta Konder Bornhausen
CollaboratorUNKNOWN
Hospital Arquidiocesano Consul Carlos Renaux
CollaboratorUNKNOWN
Hospital Universitário São Francisco na Providência de Deus (HUSF)
CollaboratorUNKNOWN
Hospital Regional de Jundiaí
CollaboratorUNKNOWN
Hospital Ruy Azeredo
CollaboratorUNKNOWN
Hospital de Base São José do Rio Preto
CollaboratorUNKNOWN
Hospital São Vicente de Paulo
CollaboratorUNKNOWN
Hospital das Clínicas da UFMG
CollaboratorUNKNOWN
Hospital de Cirurgia
CollaboratorUNKNOWN
Hospital Universitário (USP Riberão Preto)
CollaboratorUNKNOWN
Fundação Hospital do Coração Francisca Mendes
CollaboratorUNKNOWN
Hospital Dom Helder Câmara
CollaboratorUNKNOWN
Hospital Santa Casa de Curitiba
CollaboratorUNKNOWN
Hospital São Vicente de Paulo - Jundiai
CollaboratorUNKNOWN
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortalityup to 3 months during hospital admission for CABGdeath occurring at any point during the hospitalization for surgery, even if after 30 days
30-day mortality30-days of the proceduredeath occurring after discharge from the hospital, but within 30-days of the procedure

Secondary

MeasureTime frameDescription
Prolonged Hospital Staypostoperative hospital stay longer than 14 daysPostoperative hospital stay longer than 14 days, excluding in-hospital deaths
30-day readmission30-days after surgeryany unplanned admission for any reason within 30-days of CABG surgery discharge

Other

MeasureTime frameDescription
Data quality scoreAssessment will be performed on registries that have completed a 30-day active data collection period.Data quality will be assessed using a composite Aggregate Data Quality Score (ADQ), calculated as the average of three metrics: 1) Completeness (\>70% threshold): the percentage of mandatory fields populated, calculated as (Total non-missing values / Total possible values); 2) Consistency (\>90% threshold): the percentage of fields free from logical contradictions (ex.: discharge before admission) and format errors; and 3) Accuracy (\>90% threshold): the percentage of fields correctly reflecting the source electronic health record, as verified by periodic in-loco audit. The ADQ provides a single summary measure of overall registry data reliability.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026