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NCT07471698
CABG-patients, Ischemic Heart Failure
Changsha, China
View Trial DetailsNCT Number: NCT07293533
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hospital de Messejana, Fortaleza, Ceará, Brazil
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.
All inclusion steps will be guided by the coordinating center, providing clarification about the study protocol and ensuring its compliance, respecting the ethical and legal principles of the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 3 months during hospital admission for CABG
death occurring at any point during the hospitalization for surgery, even if after 30 days
Time frame: 30-days of the procedure
death occurring after discharge from the hospital, but within 30-days of the procedure
Time frame: postoperative hospital stay longer than 14 days
Postoperative hospital stay longer than 14 days, excluding in-hospital deaths
Time frame: 30-days after surgery
any unplanned admission for any reason within 30-days of CABG surgery discharge
Time frame: Assessment will be performed on registries that have completed a 30-day active data collection period.
Data quality will be assessed using a composite Aggregate Data Quality Score (ADQ), calculated as the average of three metrics: 1) Completeness (>70% threshold): the percentage of mandatory fields populated, calculated as (Total non-missing values / Total possible values); 2) Consistency (>90% threshold): the percentage of fields free from logical contradictions (ex.: discharge before admission) and format errors; and 3) Accuracy (>90% threshold): the percentage of fields correctly reflecting the source electronic health record, as verified by periodic in-loco audit. The ADQ provides a single summary measure of overall registry data reliability.
University of Sao Paulo General Hospital
Other
Estratificação de Risco em Cirurgia de revascularização miocárdica no Brasil: CABG - BraSCORE (Brazilian System for Cardiac Operative Risk Evaluation)
Acronym: BRASCORE CABG
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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