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

April 26, 2023 updated by: Yonsei University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

2046

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Tertiary care hospital

Description

Inclusion Criteria:

1) 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:

  1. patients aged <18 years
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after valvular heart surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2022-1117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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