InflammationNCT05641584
Is Monocyte/HDL Ratio a Predictor of Mortality in Aortic Valve Surgery
An observational study of Inflammation and Aortic Valve Stenosis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Aortic Valve Stenosis, HDL
- What is being tested?
- retrospective data review study
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2022to 10 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- be over the age of 18, ASA II-IV Patients scheduled for cardiac surgery due to on-pomp aortic valve replacement
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
ISTANBUL Bakırkoy Dr. Sadi Konuk Training and Research Hospital,
Istanbul, Bakırköy, 34147
About this study
Official title: The Effect of Preoperative Monocyte/HDL Ratio on Postoperative Mortality and Morbidity in Patients Undergoing Aortic Valve Replacement for Aortic Stenosis-Retrospective Study
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)
- Conditions
- Inflammation, Aortic Valve Stenosis, HDL
- Being tested
- retrospective data review study
- Medical subject headings
- Inflammation, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrospective data review studyOther
Patient information will be scanned retrospectively from the computer environment and patient cards. No intervention will be made to the patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start10 May 2022
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tuğba Yücel,MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- tuğba yücel, md, Principal investigator, Bakirkoy Dr Sadi Konuk Traning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641584
- Sponsor's protocol ID
- 2022/155
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Monocyte/HDL Ratio on Postoperative Mortality and Morbidity in Patients Undergoing Aortic Valve Replacement for Aortic Stenosis-Retrospective Study
- ClinicalTrials.gov ID
- NCT05641584
- Acronym / sponsor ID
- 2022/155
- Conditions
- Inflammation, Aortic Valve Stenosis, HDL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 10 May 2022 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- be over the age of 18, ASA II-IV Patients scheduled for cardiac surgery due to on-pomp aortic valve replacement
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrospective data review studyPatient information will be scanned retrospectively from the computer environment and patient cards. No intervention will be made to the patients. | Other | – |
Primary outcome
mortality
Time frame: 6 month
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.
morbidity
Time frame: 6 month
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.
1 secondary outcome
Inflammation
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tuğba yücel, md principal investigator
Bakirkoy Dr Sadi Konuk Traning Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Aortic Valve Stenosis, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.