Brazilian System for Cardiac Operative Risk Evaluation CABG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-07-30

Brief Summary

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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

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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

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CABG-patients

Keywords

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Databases Database Management Systems Coronary Artery Bypass Predictions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Omar Asdrúbal Vilca Mejia

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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BIANCA MARIA MAGLIA ORLANDI, Post doctoral resercher

Role: STUDY_DIRECTOR

Locations

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Hospital de Messejana

Fortaleza, Ceará, Brazil

Site Status

Hospital Alberto Urquiza Wanderley

João Pessoa, Paraíba, Brazil

Site Status

USP Heart Institute

São Paulo, São Paulo, Brazil

Site Status

Instituto Nacional de Cardiologia de Laranjeiras

Rio de Janeiro, , Brazil

Site Status

Beneficência Portuguesa de São Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND

PMID: 39109690 (View on PubMed)

Other Identifiers

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7.933.450

Identifier Type: REGISTRY

Identifier Source: secondary_id

76508623.2.1001.0068

Identifier Type: -

Identifier Source: org_study_id

Brazilian System for Cardiac Operative Risk Evaluation CABG

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Instituto Nacional de Cardiologia de Laranjeiras

Beneficência Portuguesa de São Paulo

Santa Casa de Misericórdia de Marília

Professor Fernando Figueira Integral Medicine Institute

Hospital do Coração de Messejana Dr. Carlos Alberto Studart

Instituto de Cardiologia do Rio Grande do Sul

Irmandade da Santa Casa de Misericordia de Curitiba

Hospital Universitário do Maranhão - MA

Hospital do Coração Alagoano Prof. Adib Jatene

Irmandade da Santa Casa de Misericordia de Sao Paulo

Hospital São Francisco de Assis na Providência de Deus - RJ

Hospital Universitario Pedro Ernesto

Cardiac Emergency Hospital of Pernambuco

Hospital Geral de Cuiabá

Hospital Beneficente Portuguesa de Belém

Pronto-Socorro Cardiológico Universitário de Pernambuco

Hospital Alberto Urquiza Wanderley de João Pessoa

Hospital e Maternidade Marieta Konder Bornhausen

Hospital Arquidiocesano Consul Carlos Renaux

Hospital Universitário São Francisco na Providência de Deus (HUSF)

Hospital Regional de Jundiaí

Hospital Ruy Azeredo

Hospital de Base São José do Rio Preto

Hospital São Vicente de Paulo

Hospital das Clínicas da UFMG

Hospital de Cirurgia

Hospital Universitário (USP Riberão Preto)

Fundação Hospital do Coração Francisca Mendes

Hospital Dom Helder Câmara

Hospital Santa Casa de Curitiba

Hospital São Vicente de Paulo - Jundiai

University of Sao Paulo General Hospital

Responsible Party

Omar Asdrúbal Vilca Mejia

Principal Investigators

BIANCA MARIA MAGLIA ORLANDI, Post doctoral resercher

Locations

Hospital de Messejana

Hospital Alberto Urquiza Wanderley

USP Heart Institute

Instituto Nacional de Cardiologia de Laranjeiras

Beneficência Portuguesa de São Paulo

Countries

References

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.

Related Links

Other Identifiers

7.933.450

76508623.2.1001.0068