Paulista Cardiovascular Surgery Registry I

NCT06836713 | Completed DMC

• 1 other identifier: 385312109
• Study Type: observational
• Target: 5,222
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Health Sciences; Medicine; Surgery

Outcome Measures

Primary Outcomes (1)

• Hospital mortality

  Mortality until 30 days after the surgical procedure

  Mortality until 30 days after the susrgical procedure

Interventions

Surgical Risk Stratification PROCEDURE

Database implementation to formulate a regional risk score

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Campinas, Brazil: collaborator

Study Officials

• Luiz Augusto F Lisboa, PhD

  instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de SaoPaulo, Sao Paulo, SP, BR

  STUDY DIRECTOR

• Nakazone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: February 20, 2025
• Study Start: October 1, 2013
• Primary Completion: October 30, 2015
• Study Completion: October 30, 2015
• Last Updated: February 20, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share