- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07276256
Association Between SYNTAX Score and Leukoglycemic Index In Patients Wiht Acute Coronary Syndrome
This study looks at people who come to the hospital with acute coronary syndrome, a serious heart condition. When these patients first arrive, doctors take routine blood tests. The investigators use these test results to calculate a value called the leukoglycemic index (LGI), which combines white blood cell count and blood sugar level. The investigators also use a heart imaging score called the SYNTAX score to see how complex their coronary artery disease is.
Patients are divided into two groups based on their SYNTAX scores: one group with lower scores (22 or less), and one with higher scores (above 22). The investigators compare their health data to see if LGI is linked to the severity of their heart disease. The investigators also check if LGI can help predict how complex the disease is. Information like age, family history, and chronic illnesses is collected from patient records and medical interviews.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This observational study aims to evaluate the association between the SYNTAX score-a validated angiographic tool used to assess the complexity of coronary artery disease-and the leukoglycemic index (LGI), a composite biomarker calculated from white blood cell count and blood glucose level. The study population consists of patients diagnosed with acute coronary syndrome (ACS) who were admitted to the hospital and underwent coronary angiography as part of their clinical evaluation.
At the time of initial hospital admission, routine laboratory parameters were obtained, including complete blood count and fasting glucose levels. These values were used to calculate the LGI. Patients were stratified into two groups based on their SYNTAX scores: Group I (SYNTAX score ≤22) and Group II (SYNTAX score >22). Demographic characteristics, family history of cardiovascular disease, and chronic comorbidities (such as diabetes mellitus, hypertension, and hyperlipidemia) were extracted from patient medical records and clinical anamnesis.
The primary objective of the study is to determine whether LGI correlates with the angiographic severity of coronary artery disease as measured by the SYNTAX score. Secondary objectives include identifying independent predictors of coronary complexity and evaluating the potential role of LGI as a non-invasive biomarker in risk stratification.
Statistical analyses will be performed using SPSS software. Normality of data distribution will be assessed using the Shapiro-Wilk test. Depending on distribution characteristics, appropriate parametric (e.g., Student's t-test) or non-parametric (e.g., Mann-Whitney U test) methods will be applied for group comparisons. Pearson correlation analysis will be used to assess the relationship between LGI and SYNTAX score. Multivariate linear and logistic regression models will be constructed to identify independent predictors of high SYNTAX scores, adjusting for potential confounders.
This study is expected to contribute to the understanding of LGI as a simple, cost-effective, and accessible biomarker for predicting coronary artery disease complexity in ACS patients
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kırıkkale
-
Kırıkkale, Kırıkkale, Turkey (Türkiye), 71000
- Kırıkkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18 years and older
- Patients who underwent coronary angiography due to acute coronary syndrome
Exclusion Criteria:
- Patients with diabetes mellitus (Diagnosis based on current use of oral antidiabetic or insulin therapy and/or fasting glucose level ≥126 mg/dL and HbA1c ≥6.5%)
- Patients with atrial fibrillation, history of pacemaker implantation, asthma, pulmonary hypertension, pregnancy, anemia, malignancy, rheumatoid arthritis, or peripheral artery disease
- Obese individuals (defined as body mass index [BMI] >30 kg/m²)
- Patients whose medical records could not be accessed
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
SYNTAX score =<22
|
leukoglycemic index calculation
|
|
SYNTAX score >22
|
leukoglycemic index calculation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Leukoglycemic Index (LGI)
Time Frame: First day
|
The LGI is calculated as the product of blood glucose concentration (mg/dL) and leukocyte count (cells/mm³).
This composite measure provides a single numerical value that reflects both metabolic status (via blood glucose) and hematological status (via white blood cell count).
At baseline, LGI serves as an integrated indicator of participants' metabolic and immune activity.
It is simple to compute and offers a practical way to capture two fundamental aspects of health in one measure.
Higher values are considered worse outcomes because they reflect an increased metabolic and inflammatory burden
|
First day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.05.19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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