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Cardiac Surgical ProceduresREPLICCARNCT05363696

The REPLICCAR Registry and The Statewide Quality Improvement Initiative

An observational study of Cardiac Surgical Procedures, run by University of Sao Paulo General Hospital at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Cardiac Surgical Procedures
What is being tested?
Coronary artery bypass grafting (CABG) and Heart valve surgery
Type of treatment
Surgery or procedure
How many people
9,723 participants
Where
2 sitesBrazil
Study dates
1 Aug 2013to 1 Aug 2019
How long will I take part?
30 Days
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients (18-90 years old) underwent cardiac surgery.

Who may be able to join

  • Age 18- 90 years old.
  • CABG or heart valve surgery
  • Agreement to participate in the study signing informed consent documentation.

Who cannot join

  • Re-operation
  • Impossibility to access data variables relevant to the study.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • USP Heart Institute

    São Paulo, 05403-900

  • Fabio B Jatene, MD, PhD

    São Paulo, 05409011

Other trials in Brazil

About this study

Official title: Paulista Cardiovascular Surgery Registry (REPLICCAR)

Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes, and structure. When the rate of growth of healthcare costs scenario is greater than the one of Gross Domestic Product of countries, there is a considerable challenge to increment the quality of healthcare services and the primordial patient safety, as well as the necessary control and traceability of implantable devices. The association and correlation of patients' demographic and clinically relevant information with the resources required for the care provided for each stratum represent the possibility to adapt, improve and innovate the healthcare programs; This will allow improving the optimization of the therapeutic protocols and the creation of related research areas, aiming to promote more equitable resources allocation, increase access and effectiveness, as well as to ascertain the magnitude of available and used resources and its impact.

Read the detailed description

METHODS Extension Cohort study, mandatory, prospective multicenter, in the state of São Paulo and of registry of consecutive cases. Besides the situational diagnostic of the results and comparison between the mean of both registries, there will be the creation of improvement reports for each of the REPLICCAR centers.

Next, quality improvement initiatives will be implemented in each center indicated by the reports.

Sample

  • Will be included in a consecutive way all patients that had CABG and heart valve surgery in the participant centers for the defined period;
  • Data will be collected, independently of surgical volume, severity status, and social condition among others, in sight of the São Paulo state health department;
  • This way, it will be possible to produce a predictive curve to be used in most clinical case scenarios observed in the state of São Paulo;
Being tested
Coronary artery bypass grafting (CABG), Heart valve surgery
Keywords
Database, Quality improvement, Mortality, Coronary artery bypass grafting, Heart valve surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary artery bypass grafting (CABG)Procedure or surgery

    Coronary artery bypass grafting surgery procedure

  • Heart valve surgeryProcedure or surgery

    Heart valve surgery procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state

    Guided by the database, quality initiatives will be built in order to reduce mortality, length of stay and complications in the centers participating in REPLICCAR.

    Measured: 5 years

Secondary outcomes (3)

  1. Create a morbidity and mortality risk score

    Create a morbidity and mortality risk score, in order to guide the care and interventions of patients undergoing cardiac procedures, in order to prevent morbidity and mortality outcomes.

    Measured: 5 years

  2. Long-term follow-up of patients included in the database

    Long-term follow-up of patients included in the database, providing an opportunity to assess quality of life, evolution and deaths after hospital discharge.

    Measured: 10 years

  3. Assessment of the impact of patients' socioeconomic variation in its surgical evolution

    Assessment of the impact of patients' socioeconomic variation on their evolution in terms of morbidity and mortality (short and long term).

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start1 Aug 2013
  3. Primary completion1 Sep 2016
  4. Study completion1 Aug 2019

Resources

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
9,723 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363696
Sponsor's protocol ID
450617006
Acronym
REPLICCAR
Status last verified
May 2019
First submitted
2 May 2022
Last updated
25 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The Comissão de Ética para Análise de Projetos de Pesquisa (CAPPesq) - HC-FMUSP https://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 ) approved this analysis as part of the Project: "Surgical Risk Stratification as an Instrument for Innovation in Cardiac Surgery Programs in the Unified Health System of the São Paulo State " (REPLICCAR 1) under online registration Nº.450617006. This retrospective analysis was performed without identifying the patients. Therefore, patients' informed consent form was waived.

Publications

  • Orlandi BMM, Mejia OAV, Borgomoni GB, Goncharov M, Rocha KN, Bassolli L, Melo de Barros E Silva PG, Nakazone MA, Sousa A, Campagnucci VP, de Sousa Vilarinho KA, Katz M, Tiveron MG, Arrais Dos Santos M, Lisboa LAF, Dallan LAO, Jatene FB; REPLICCAR II Study Group. REPLICCAR II Study: Data quality audit in the Paulista Cardiovascular Surgery Registry. PLoS One. 2020 Jul 10;15(7):e0223343. doi: 10.1371/journal.pone.0223343. eCollection 2020.

    PubMed 32649718

  • Borgomoni GB, Dias RD, de Barros E Silva PGM, Nakazone MA, de Oliveira MAP, Campagnucci VP, Tiveron MG, Lisboa LAF, Hajjar LA, Zubelli JP, Jatene FB, Mejia OAV; REPLICCAR study group. Incidence of failure-to-rescue after coronary artery bypass grafting: a multicenter observational study from the REPLICCAR II registry in Brazil. Patient Saf Surg. 2025 Feb 11;19(1):6. doi: 10.1186/s13037-024-00417-9.

    PubMed 39934891

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Surgical Procedures, run by University of Sao Paulo General Hospital at 2 sites in Brazil.

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 3 inclusion and 2 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05363696, which also lists 2 linked publications.

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 25 May 2022.

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