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CompletedNCT06836713REPLICCAR IUpdated Feb 20, 2025

Paulista Cardiovascular Surgery Registry I

An observational study in Health Sciences, Medicine and Surgery, sponsored by University of Sao Paulo General Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by University of Sao Paulo General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,222
Ages
18 Years and older
Sex
All
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Study 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)

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Conditions studied

  • Health Sciences
  • Medicine
  • Surgery
03

In context

Lead sponsor

University of Sao Paulo General Hospital is the lead sponsor of 595 studies on the registry; 98 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,222 participants (actual)
Patient registry
No

Interventions

  • ProcedureSurgical Risk Stratification

    Database implementation to formulate a regional risk score

06

What researchers measure

Primary outcomes

  1. Hospital mortality

    Mortality until 30 days after the surgical procedure

    Time frame: Mortality until 30 days after the susrgical procedure

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — 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).

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06836713
Lead sponsor
University of Sao Paulo General Hospital
Collaborators
University of Campinas, Brazil
Responsible party
Sponsor
First posted
Feb 20, 2025
Start date
Oct 1, 2013
Primary completion
Oct 30, 2015
Completion
Oct 30, 2015
Last update
Feb 20, 2025

Study contacts

Luiz Augusto F Lisboa, PhD
study director · instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de SaoPaulo, Sao Paulo, SP, BR
Nakazone
principal investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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