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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYNTAX score =<22 |
| ||
| SYNTAX score >22 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leukoglycemic index calculation | Other | leukoglycemic index calculation |
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| Measure | Description | Time Frame |
|---|---|---|
| Leukoglycemic Index (LGI) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute coronary syndrome
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kırıkkale university | Kirikkale | Kırıkkale | 71000 | Turkey (Türkiye) |
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Inclusion Criteria
Exclusion Criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | SYNTAX Score =<22 | Participants with coronary artery disease and a SYNTAX score ≤ 22 will be allocated to this group.
Eligibility Criteria for Assignment:
|
| FG001 | SYNTAX Score >22 | Participants with coronary artery disease whose baseline SYNTAX score is greater than 22. This reflects moderate-to-high anatomical complexity and is commonly associated with increased procedural risk and event rates after revascularization. If relevant to the protocol, this arm can be sub-stratified into 23-32 (moderate) and ≥33 (high) complexity cohorts.
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| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SYNTAX Score =<22 | Participants with coronary artery disease and a SYNTAX score ≤ 22 will be allocated to this group.
Eligibility Criteria for Assignment:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Leukoglycemic Index (LGI) | 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 | Posted | Median | Full Range | mg/dL*cells per mm^3 | First day |
|
Adverse events were not monitored/assessed during the study
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SYNTAX Score =<22 | Participants with coronary artery disease and a SYNTAX score ≤ 22 will be allocated to this group.
Eligibility Criteria for Assignment:
|
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There was no limitation about the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rukiye GONEN OZDEMIR | Kırıkkale University, Faculty of Medicine, Department of Cardiology | 05054503953 | +90 | rukiye_gonen@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2025 | Feb 7, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| BG001 | SYNTAX Score >22 | Participants with coronary artery disease whose baseline SYNTAX score is greater than 22. This reflects moderate-to-high anatomical complexity and is commonly associated with increased procedural risk and event rates after revascularization. If relevant to the protocol, this arm can be sub-stratified into 23-32 (moderate) and ≥33 (high) complexity cohorts.
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Leucoglycemic Index (LGI) | 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. | Median | Full Range | mg/dL*cells per mm^3 |
|
| OG001 | SYNTAX Score >22 | Participants with coronary artery disease whose baseline SYNTAX score is greater than 22. This reflects moderate-to-high anatomical complexity and is commonly associated with increased procedural risk and event rates after revascularization. If relevant to the protocol, this arm can be sub-stratified into 23-32 (moderate) and ≥33 (high) complexity cohorts.
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SYNTAX Score >22 | Participants with coronary artery disease whose baseline SYNTAX score is greater than 22. This reflects moderate-to-high anatomical complexity and is commonly associated with increased procedural risk and event rates after revascularization. If relevant to the protocol, this arm can be sub-stratified into 23-32 (moderate) and ≥33 (high) complexity cohorts.
| 0 | 0 | 0 | 0 | 0 | 0 |
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| D003327 |
| Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |