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OpenTrials
Completed

NCT Number: NCT06836713

Paulista Cardiovascular Surgery Registry I

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Surgical Risk Stratification

Procedure

Database implementation to formulate a regional risk score

Primary outcomes

  1. Hospital mortality

    Time frame: Mortality until 30 days after the susrgical procedure

    Mortality until 30 days after the surgical procedure

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • University of Campinas, Brazil

Registry information

Official study title

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

Acronym: REPLICCAR I

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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