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临床试验/NCT07293533
NCT07293533Enrolling By Invitation不适用

Estratificação de Risco em Cirurgia de revascularização miocárdica no Brasil: CABG - BraSCORE (Brazilian System for Cardiac Operative Risk Evaluation)

University of Sao Paulo General Hospital5 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
2,400
试验地点
5
主要终点
In-hospital mortality

研究概览

简要总结

Grouping relevant demographic and clinical information at specific stratified levels, and in correlation with the required resource sets, represents the possibility to adapt, improve, and innovate in cardiac surgery programs. In this path, the pursuit of implementing large databases for continuous improvement cycles becomes the foundation of the entire process. In Brazil, where structural and socioeconomic differences are significant, the standardization and sustainability of a large database become a major challenge. Projects like REPLICCAR (São Paulo Cardiovascular Surgery Registry) and BYPASS Registry, which were created to identify improvement opportunities, were temporary. The absence of a continuous multicenter registry makes it difficult to understand risk-adjusted patient outcomes and to implement cost-effective quality initiatives. For example, in 2022, the Ministry of Health launched the QualiSUS Cardio program, which began to consider hospital reimbursement not only in terms of surgical volume but also in relation to mortality, length of stay, and readmission rates after cardiac surgery. Changes like this already occur in various scenarios where payers, whether public or private, seek reimbursement through value-based models. However, for this to happen, the results need to be adjusted to patient risk. Otherwise, hospitals treating more severe patients would be at a disadvantage. This study aims to develop CABG-BraSCORE, a risk score to stratify patients referred for CABG surgery, adjusting outcomes to patient risk, and seeking continuous improvement for cardiac surgery programs in Brazil.

详细描述

Study Procedure: Data collection will be conducted from patient records, including demographic characteristics, preoperative status, surgical and postoperative data of CABG surgery, and follow-up up to 30 days post-discharge.

Centers with prospective data collection: Participants will be contacted 30 days after surgery and invited to participate in the study. The Free and Informed Consent Form (FICF) will be applied via telephone (Appendix 1). All FICF sessions will be recorded, downloaded, and stored according to the established study protocols.

Centers with retrospective data collection: Thirty days after surgery, it should be recorded whether there was a return visit to the outpatient clinic, readmission to the institution, the reason for readmission, such as surgical complications, stroke, surgical wound infection, myocardial infarction, and mortality at 30 days. All records should be consulted in the patient's medical record. If there is no information recorded about the patient's return visit, loss to follow-up should be considered. A loss of 20% was considered for the sample composition.

After the telephone FICF, a questionnaire (Appendix 2, within the Cardux platform's "Post-discharge Events" section) will be applied to gather information regarding readmissions, death, adverse events, among others, within 30 days after hospital discharge.

Patient data will be entered into the Cardux platform according to study protocol variables.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients submitted to isolated coronary artery bypass grafting at participating centers

排除标准

  • Emergency or salvage CABG procedures.
  • Associated procedures (e.g., valve surgery, aortic surgery).
  • Missing mandatory data in the registry.

结局指标

主要结局

In-hospital mortality

时间窗: up to 3 months during hospital admission for CABG

death occurring at any point during the hospitalization for surgery, even if after 30 days

30-day mortality

时间窗: 30-days of the procedure

death occurring after discharge from the hospital, but within 30-days of the procedure

次要结局

  • Prolonged Hospital Stay(postoperative hospital stay longer than 14 days)
  • 30-day readmission(30-days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Asdrúbal Vilca Mejia

MD PhD

University of Sao Paulo General Hospital

研究点 (5)

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