A Prediction Model for 1-year Mortality After Valvular Heart Surgery

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05833256

Collaborator

(none)

2,046

Enrollment

Location

Anticipated Duration (Months)

186.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Undergoing Valvular Heart Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

2046 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Outcome Measures

Primary Outcome Measures

1-year mortality after valvular heart surgery [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 Outcome Measures

neutrophil-to-lymphocyte ratio (NLR), calculated as the number of neutrophils divided by the number of lymphocytes [within 1 month before surgery]
the white blood cell count with (neutrophil)
monocyte-to-lymphocyte ratio (MLR), calculated as the number of monocytes divided by the number of lymphocytes [within 1 month before surgery]
the white blood cell count with ( monocyte)
platelet-to-lymphocyte ratio (PLR), calculated as the number of platelets divided by the number of lymphocytes [within 1 month before surgery]
the white blood cell count with platelet

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Jin Sun Cho, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05833256

Other Study ID Numbers:

4-2022-1117

First Posted:

Apr 27, 2023

Last Update Posted:

Apr 27, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 27, 2023