Health SciencesREPLICCAR INCT06836713
Paulista Cardiovascular Surgery Registry I
An observational study of Health Sciences and Medicine, run by University of Sao Paulo General Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Sciences, Medicine, Surgery
- What is being tested?
- Surgical Risk Stratification
- Type of treatment
- Surgery or procedure
- How many people
- 5,222 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 30 Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery (coronary artery bypass grafting and/or heart valve surgery)
Who may be able to join
- 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
Who cannot join
- Patients operated on in an emergency or rescue situation and who underwent percutaneous or transcatheter procedures were excluded from this analysis.
About this study
Official title: 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)
- Conditions
- Health Sciences, Medicine, Surgery
- Being tested
- Surgical Risk Stratification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Risk StratificationProcedure or surgery
Database implementation to formulate a regional risk score
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Mortality until 30 days after the surgical procedure
Measured: Mortality until 30 days after the susrgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Oct 2013
- Primary completion30 Oct 2015
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health SciencesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil
- Responsible party
- Sponsor
- Investigators
- Luiz Augusto F Lisboa, PhD, Study director, instituto do Coração, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de SaoPaulo, Sao Paulo, SP, BRNakazone, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836713
- Sponsor's protocol ID
- 385312109
- Acronym
- REPLICCAR I
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Risk Stratification As an Instrument for Innovation in Cardiac Surgery Programs in the Unified Health System of the São Paulo State
- ClinicalTrials.gov ID
- NCT06836713
- Acronym / sponsor ID
- REPLICCAR I / 385312109
- Conditions
- Health Sciences, Medicine, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,222 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 30 Oct 2015 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery (coronary artery bypass grafting and/or heart valve surgery)
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients operated on in an emergency or rescue situation and who underwent percutaneous or transcatheter procedures were excluded from this analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Risk StratificationDatabase implementation to formulate a regional risk score | Procedure or surgery | – |
Primary outcome
Hospital mortality
Time frame: Mortality until 30 days after the susrgical procedure
Mortality until 30 days after the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Health Sciences and Medicine, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: Mortality until 30 days after the susrgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.