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Completed

NCT Number: NCT05363696

The REPLICCAR Registry and The Statewide Quality Improvement Initiative

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.

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Key information

Conditions

Cardiac Surgical Procedures

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fabio B Jatene, MD, PhD, São Paulo, Brazil

Loading trial locations.

About this study

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;

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary artery bypass grafting (CABG)

Procedure

Coronary artery bypass grafting surgery procedure

Heart valve surgery

Procedure

Heart valve surgery procedure

Primary outcomes

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

    Time frame: 5 years

    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.

Secondary outcomes

  1. Create a morbidity and mortality risk score

    Time frame: 5 years

    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.

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

    Time frame: 10 years

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

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

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Beneficência Portuguesa de São Paulo
  • Hospital Israelita Albert Einstein
  • Hospital Pitangueiras do Grupo SOBAM
  • Hospital Samaritano Paulista
  • Hospital São Paulo da Universidade Federal de São Paulo
  • Hospital das Clinicas da Universidade Estadual de Campinas
  • Hospital de Base
  • Instituto Dante Pazzanese de Cardiologia
  • Irmandade da Santa Casa de Misericórdia de Marília
  • Irmandade da Santa Casa de Misericórdia de Piracicaba
  • Irmandade da Santa Casa de Misericórdia de São Paulo
  • University of Sao Paulo

Registry information

Official study title

Paulista Cardiovascular Surgery Registry (REPLICCAR)

Acronym: REPLICCAR

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
May 6, 2022
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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