The REPLICCAR Registry and The Statewide Quality Improvement Initiative

NCT ID: NCT05363696

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9723 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-01
• Study Completion Date: 2019-08-01

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.

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;

Conditions

Cardiac Surgical Procedures

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Coronary artery bypass grafting (CABG)

Coronary artery bypass grafting surgery procedure

Intervention Type: PROCEDURE

Heart valve surgery

Heart valve surgery procedure

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

UNKNOWN

Sponsor Role: collaborator

Hospital Samaritano Paulista

OTHER

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: collaborator

Beneficência Portuguesa de São Paulo

OTHER

Sponsor Role: collaborator

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: collaborator

Hospital das Clinicas da Universidade Estadual de Campinas

UNKNOWN

Sponsor Role: collaborator

Hospital de Base de São Jose do Rio Preto

UNKNOWN

Sponsor Role: collaborator

Irmandade da Santa Casa de Misericórdia de Marília

UNKNOWN

Sponsor Role: collaborator

Irmandade da Santa Casa de Misericórdia de São Paulo

UNKNOWN

Sponsor Role: collaborator

Irmandade da Santa Casa de Misericórdia de Piracicaba

UNKNOWN

Sponsor Role: collaborator

Hospital São Paulo da Universidade Federal de São Paulo

UNKNOWN

Sponsor Role: collaborator

Hospital Pitangueiras do Grupo SOBAM

UNKNOWN

Sponsor Role: collaborator

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

UNKNOWN

Sponsor Role: collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omar AV Mejia, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

USP Heart Institute

Locations

USP Heart Institute

São Paulo, , Brazil

Fabio B Jatene, MD, PhD

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 32649718 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39934891 (View on PubMed)

Other Identifiers

450617006

Identifier Type: -

Identifier Source: org_study_id