Paulista Cardiovascular Surgery Registry I (REPLICCAR I)

Surgical Risk Stratification As an Instrument for Innovation in Cardiac Surgery Programs in the Unified Health System of the São Paulo State

Cardiovascular diseases represent the greatest burden of morbidity and mortality for the health system and cardiac surgery has an important impact on their resolutivity. The association and correlation of patients' demographic and clinical relevant information with the resources required for each stratum represent the possibility to adapt, improve and innovate into the healthcare programs. This project aims to remodel the "InsCor" risk score for the formulation of the SP- SCORE (Sao Paulo System for Cardiac Operative Risk Evaluation) in order to better reflects the complexity of cardiac surgical care, The participating hospitals include the Health Technology Assessment Centers in of the Health Secretarlat'HTA Network of São Paulo State (HTA-NATSs / SES-SP). The SP-SCORE will use 10 variables of the InsCor model and others 8 variables with presumed influence in Brazil. The primary endpoints are morbidity and mortality. This project will contribute for the SUS- SP regionalized health-care (RRAS) sustainability and financing of the CABG and/or heart valve surgery programs promoting equitable allocation, increasing access and effectiveness, as well as characterizing the magnitude of available resources and its impact. (AU)

Study Overview

• Status: Completed
• Conditions: Surgery; Health Sciences; Medicine
• Intervention / Treatment: Procedure: Surgical Risk Stratification

• Study Type: Observational
• Enrollment (Actual): 5222

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac surgery (coronary artery bypass grafting and/or heart valve surgery)

Description

Inclusion Criteria:

• Patients who underwent isolated coronary artery bypass grafting (CABG) surgery, mitral valve surgery, aortic valve surgery, combined mitral + aortic valve surgery, and CABG + heart valve surgery

Exclusion Criteria:

• Patients operated on in an emergency or rescue situation and who underwent percutaneous or transcatheter procedures were excluded from this analysis.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital mortality	Mortality until 30 days after the surgical procedure	Mortality until 30 days after the susrgical procedure

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: University of Campinas, Brazil
• Investigators: Study Director: Luiz Augusto F Lisboa, PhD, instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de SaoPaulo, Sao Paulo, SP, BR; Principal Investigator: Nakazone

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): October 30, 2015
• Study Completion (Actual): October 30, 2015

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 385312109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data underlying this study cannot be made available due to ethical restrictions; patients did not consent to their de-identified data being publicly shared. De-identified data can be made available to qualified researchers under their responsibility and assuming the penalties if public disclosure of the data. Data requests should be sent to Renata do Val, Director of the Scientific Committee, Ethics Committee of the Heart Institute-University of São Paulo (renata.doval@incor.usp.br, http://www.incor.usp.br/sites/incor2013/index.php/equipe/16-pesquisa/comissao-cientifica/158-fale-conosco) or Prof. Dr. Alfredo José Mansur, Coordinator, Comissão de Ética para Análise de Projetos de Pesquisa-CAPPesq (cappesq.adm@hc.fm.usp.br, http://www.hc.fm.usp.br/index.php?option=com_content&view=article&id=243:comissao-de-etica-para-analise-de-projetos-de-pesquisa-do-hcfmusp&catid=23&Itemid=229).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No