The REPLICCAR Registry and The Statewide Quality Improvement Initiative

NCT05363696 | Completed

• 1 other identifier: 450617006
• Study Type: observational
• Target: 9,723
• Locations: 1 country
• Sites: 2

Brief 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, 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.

Conditions

Cardiac Surgical Procedures

Keywords

Database; Quality improvement; Mortality; Coronary artery bypass grafting; Heart valve surgery

Outcome Measures

Primary Outcomes (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.

  5 years

Secondary Outcomes (3)

• Create a morbidity and mortality risk score

  5 years

• Long-term follow-up of patients included in the database

  10 years

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

  10 years

Interventions

Coronary artery bypass grafting (CABG) PROCEDURE

Coronary artery bypass grafting surgery procedure

Heart valve surgery PROCEDURE

Heart valve surgery procedure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo: collaborator
• Hospital Samaritano Paulista: collaborator
• Hospital Israelita Albert Einstein: collaborator
• Beneficência Portuguesa de São Paulo: collaborator
• Instituto Dante Pazzanese de Cardiologia: collaborator
• Hospital das Clinicas da Universidade Estadual de Campinas: collaborator
• Hospital de Base de São Jose do Rio Preto: collaborator
• Irmandade da Santa Casa de Misericórdia de Marília: collaborator
• Irmandade da Santa Casa de Misericórdia de São Paulo: collaborator
• Irmandade da Santa Casa de Misericórdia de Piracicaba: collaborator
• Hospital São Paulo da Universidade Federal de São Paulo: collaborator
• Hospital Pitangueiras do Grupo SOBAM: collaborator
• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP: collaborator

Study Sites (2)

USP Heart Institute

São Paulo, 05403-900, Brazil

Location

Fabio B Jatene, MD, PhD

São Paulo, 05409011, Brazil

Location

Related Publications (2)

• 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.

  PMID: 32649718 RESULT

• 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.

  PMID: 39934891 DERIVED

MeSH Terms

Interventions

Coronary Artery Bypass

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Omar AV Mejia, MD,PhD

  USP Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 6, 2022
• Study Start: August 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: August 1, 2019
• Last Updated: May 25, 2022

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)