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Clinical Trials/NCT05833256
NCT05833256
Recruiting
Not Applicable

Inflammation-related Markers for the Prediction of Postoperative 1-year Mortality in Patients Undergoing Valvular Heart Surgery

Yonsei University1 site in 1 country2,046 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients Undergoing Valvular Heart Surgery
Sponsor
Yonsei University
Enrollment
2046
Locations
1
Primary Endpoint
1-year mortality after valvular heart surgery
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The investigators aimed to develop a predictive model for mortality incorporating nutritional, inflammatory, and perioperative factors in patients undergoing valvular heart surgery. In this retrospective study, the investigators aimed to establish a comprehensive prediction model to predict the risk of 1-year mortality in valvular heart surgery patients through the identification of the inflammatory index most associated with 1-year mortality and developing a prognostic nomogram model incorporating perioperative risk factors with nutritional and inflammatory indices that would be verified by validation cohorts.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
October 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients who presented for surgery primarily due to valvular heart disease, including those who required concomitant coronary artery bypass surgery, aortic procedures, or other cardiac procedures.

Exclusion Criteria

  • patients aged \<18 years
  • undergoing transcatheter valve replacement, combined congenital heart surgery, or implantation of ventricular assist device, 3) lacking data required for calculating inflammatory indices, or 4) follow-up loss.

Outcomes

Primary Outcomes

1-year mortality after valvular heart surgery

Time Frame: 1 year after valvular heart surgery

Mortality at follow-up was analysed using time-to-event analysis, with survival time defined as the time from date of surgery until date of death.

Secondary Outcomes

  • neutrophil-to-lymphocyte ratio (NLR), calculated as the number of neutrophils divided by the number of lymphocytes(within 1 month before surgery)
  • monocyte-to-lymphocyte ratio (MLR), calculated as the number of monocytes divided by the number of lymphocytes(within 1 month before surgery)
  • platelet-to-lymphocyte ratio (PLR), calculated as the number of platelets divided by the number of lymphocytes(within 1 month before surgery)

Study Sites (1)

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