NCT05641584

Brief Summary

In this study, the investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic stenosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2022

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

November 29, 2022

Last Update Submit

December 12, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • mortality

    The investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality in patients who underwent aortic valve replacement due to aortic stenosis.

    6 month

  • morbidity

    The investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and The investigators aimed to determine whether the preoperative Monocyte/HDL ratio would be a predictor of postoperative mortality and morbidity in patients who underwent aortic valve replacement due to aortic stenosis. in patients who underwent aortic valve replacement due to aortic stenosis.

    6 month

Secondary Outcomes (1)

  • Inflammation

    6 month

Interventions

Patient information will be scanned retrospectively from the computer environment and patient cards. No intervention will be made to the patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients included in the study Adult patients (aged ≥18 years) with ASA II-IV who underwent elective aortic valve replacement under Cardiopulmonary bypass (CPB) for aortic stenosis in our clinic between January 1, 2010 and March 31, 2022, were retrospectively scanned from the computer system and patient cards, and included in the study.

You may qualify if:

  • be over the age of 18, ASA II-IV Patients scheduled for cardiac surgery due to on-pomp aortic valve replacement

You may not qualify if:

  • emergency operations, off pump)pumpless surgery, revision (repetitive) operations, those with signs of acute infection, those with autoimmune disease, those with severe renal (serum creatinine \>2.0 mg/dl) disease, those with severe hepatic disease, those with suspected malignancy, patients where data variables cannot be saved due to technical problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ISTANBUL Bakırkoy Dr. Sadi Konuk Training and Research Hospital,

Istanbul, Bakırköy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

InflammationAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • tuğba yücel, md

    Bakirkoy Dr Sadi Konuk Traning Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 7, 2022

Study Start

May 10, 2022

Primary Completion

July 10, 2022

Study Completion

July 10, 2022

Last Updated

December 14, 2022

Record last verified: 2022-12

Locations