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Enrolling by Invitation

NCT Number: NCT07293533

Brazilian System for Cardiac Operative Risk Evaluation CABG

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Messejana, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. In-hospital mortality

    Time frame: up to 3 months during hospital admission for CABG

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

  2. 30-day mortality

    Time frame: 30-days of the procedure

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

Secondary outcomes

  1. Prolonged Hospital Stay

    Time frame: postoperative hospital stay longer than 14 days

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

  2. 30-day readmission

    Time frame: 30-days after surgery

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

Other outcomes

  1. Data quality score

    Time frame: Assessment 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BRASCORE CABG

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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