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CompletedNCT05641584Updated Dec 14, 2022

Is Monocyte/HDL Ratio a Predictor of Mortality in Aortic Valve Surgery

An observational study in Inflammation, Aortic Valve Stenosis and HDL, sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-14.

Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Inflammation is causally associated with both coronary artery disease and aortic stenosis. Although aortic stenosis is considered a static degenerative and calcific process, recent evidence has shown the opposite. The role of inflammation in the pathogenesis of AS It will be investigated that mortality may be associated with increased inflammation in patients treated with AVR.

Adult patients (aged ≥18 years) with ASA II-IV who underwent elective aortic valve replacement under cardiopulmonary bypass (CPB) due to aortic stenosis in our clinic between January 1, 2010 and March 31, 2022, will be included in the study by retrospectively scanned from the computer system and patient cards. The exclusion criteria from the study are as follows; 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.

Demographic characteristics of patients (age, gender, body mass index, diabetes mellitus, hypertension, chronic kidney disease-failure, peripheral vascular disease, smoking history, hyperlipidemia, atrial fibrillation history, left ventricular ejection fraction, coronary artery disease history, Cabg history) Europe Cardiac Operative Risk Assessment System II (EuroSCORE), Systemic Immune-Inflammatory Index (SII), APACHE II, SOFA Score, NYHA III/IV values, drugs used (ASA, oral anticoagulants, beta blocker, statin, ACE inh., ARB) , preoperative glucose, HbA1c, urea, creatinine, total cholesterol, LDL, HDL, triglyceride, hemoglobin, hematocrit, platelet, WBC, neutrophil, lymphocyte, monocytes, monocyte/HDL ratio, CRP, preoperative and postoperative EF and PAB values, ICU admission duration, duration of invasive mechanical ventilation, type of discharge, amount of ES replaced will be recorded. Operation time, cardiopulmonary bypass (extracorporeal circulation) time, cross clamp time, inotropic and vasopressor requirements will be recorded)

02

Conditions studied

  • Inflammation
  • Aortic Valve Stenosis
  • HDL
03

In context

Inflammation

3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.

This study's enrollment of 1 is below the median of 95 across 913 observational studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 120 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1 participant (actual)
Patient registry
No

Interventions

  • Otherretrospective data review study

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 month

  2. 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.

    Time frame: 6 month

Secondary outcomes

  1. Inflammation

    Inflammation is causally associated with both coronary artery disease and aortic stenosis. Although aortic stenosis is considered a static degenerative and calcific process, recent evidence has shown the opposite. The role of inflammation in the pathogenesis of AS It will be investigated that mortality may be associated with increased inflammation in patients treated with AVR.

    Time frame: 6 month

07

Study locations

1 site
  • ISTANBUL Bakırkoy Dr. Sadi Konuk Training and Research Hospital,
    Istanbul, Bakırköy 34147, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05641584
Responsible party
Tuğba Yücel,MD (Principal Investigator, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Principal investigator
First posted
Dec 7, 2022
Start date
May 10, 2022
Primary completion
Jul 10, 2022
Completion
Jul 10, 2022
Last update
Dec 14, 2022

Study contacts

tuğba yücel, md
principal investigator · Bakirkoy Dr Sadi Konuk Traning Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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