Trial Outcomes & Findings for Association Between SYNTAX Score and Leukoglycemic Index In Patients Wiht Acute Coronary Syndrome (NCT NCT07276256)
NCT ID: NCT07276256
Last Updated: 2026-02-25
Results Overview
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
COMPLETED
552 participants
First day
2026-02-25
Participant Flow
Inclusion Criteria * Adults aged ≥18 years * Patients undergoing coronary angiography due to acute coronary syndrome * Non-obese patients Exclusion Criteria * Patients \<18 years of age * Patients with diabetes mellitus (diagnosed by ongoing oral or insulin therapy and/or fasting glucose ≥126 mg/dL with HbA1c ≥6.5%) * Patients with atrial fibrillation, pacemaker history, asthma, pulmonary hypertension, pregnancy, anemia, malignancy, rheumatoid arthritis, peripheral artery disease * Obese patient
Participant milestones
| Measure |
SYNTAX Score =<22
Participants with coronary artery disease and a SYNTAX score ≤ 22 will be allocated to this group.
* SYNTAX score is an angiographic tool used to grade the complexity of coronary artery disease.
* A score ≤ 22 indicates low anatomical complexity, typically associated with favorable outcomes after percutaneous coronary intervention (PCI).
* This group will serve as the comparator for higher SYNTAX score arms, or as the primary treatment arm depending on study design.
Eligibility Criteria for Assignment:
* Patients undergoing coronary angiography with confirmed multivessel or left main coronary artery disease.
* Calculated SYNTAX score ≤ 22 at baseline.
* Meeting all other inclusion/exclusion criteria of the trial.
|
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.
* Eligibility criteria for assignment:
* Confirmed CAD: Multivessel and/or left main disease on coronary angiography.
* SYNTAX score: \> 22 calculated at baseline by two independent readers or core lab per protocol.
* General trial criteria: Meets all inclusion/exclusion criteria (hemodynamic stability, renal function thresholds, etc.).
|
|---|---|---|
|
Overall Study
STARTED
|
400
|
152
|
|
Overall Study
COMPLETED
|
400
|
152
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
SYNTAX Score =<22
n=400 Participants
Participants with coronary artery disease and a SYNTAX score ≤ 22 will be allocated to this group.
* SYNTAX score is an angiographic tool used to grade the complexity of coronary artery disease.
* A score ≤ 22 indicates low anatomical complexity, typically associated with favorable outcomes after percutaneous coronary intervention (PCI).
* This group will serve as the comparator for higher SYNTAX score arms, or as the primary treatment arm depending on study design.
Eligibility Criteria for Assignment:
* Patients undergoing coronary angiography with confirmed multivessel or left main coronary artery disease.
* Calculated SYNTAX score ≤ 22 at baseline.
* Meeting all other inclusion/exclusion criteria of the trial.
|
SYNTAX Score >22
n=152 Participants
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.
* Eligibility criteria for assignment:
* Confirmed CAD: Multivessel and/or left main disease on coronary angiography.
* SYNTAX score: \> 22 calculated at baseline by two independent readers or core lab per protocol.
* General trial criteria: Meets all inclusion/exclusion criteria (hemodynamic stability, renal function thresholds, etc.).
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 12.7 • n=400 Participants
|
63.6 years
STANDARD_DEVIATION 14.1 • n=152 Participants
|
60.1 years
STANDARD_DEVIATION 13.3 • n=552 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=400 Participants
|
34 Participants
n=152 Participants
|
118 Participants
n=552 Participants
|
|
Sex: Female, Male
Male
|
316 Participants
n=400 Participants
|
118 Participants
n=152 Participants
|
434 Participants
n=552 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Leucoglycemic Index (LGI)
|
1.081 mg/dL*cells per mm^3
n=400 Participants
|
1.230 mg/dL*cells per mm^3
n=152 Participants
|
1.089 mg/dL*cells per mm^3
n=552 Participants
|
PRIMARY outcome
Timeframe: First dayThe 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
Outcome measures
| Measure |
SYNTAX Score =<22
n=400 Participants
Participants with coronary artery disease and a SYNTAX score ≤ 22 will be allocated to this group.
* SYNTAX score is an angiographic tool used to grade the complexity of coronary artery disease.
* A score ≤ 22 indicates low anatomical complexity, typically associated with favorable outcomes after percutaneous coronary intervention (PCI).
* This group will serve as the comparator for higher SYNTAX score arms, or as the primary treatment arm depending on study design.
* Eligibility Criteria for Assignment:
* Patients undergoing coronary angiography with confirmed multivessel or left main coronary artery disease.
* Calculated SYNTAX score ≤ 22 at baseline.
* Meeting all other inclusion/exclusion criteria of the trial.
|
SYNTAX Score >22
n=152 Participants
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.
* Eligibility criteria for assignment:
* Confirmed CAD: Multivessel and/or left main disease on coronary angiography.
* SYNTAX score: \> 22 calculated at baseline by two independent readers or core lab per protocol.
* General trial criteria: Meets all inclusion/exclusion criteria (hemodynamic stability, renal function thresholds, etc.).
|
|---|---|---|
|
Leukoglycemic Index (LGI)
|
1.081 mg/dL*cells per mm^3
Full Range 0.830-1.410 • Interval 0.83 to 1.41
|
1.230 mg/dL*cells per mm^3
Full Range 0.825-1.743 • Interval 0.825 to 1.743
|
Adverse Events
SYNTAX Score =<22
SYNTAX Score >22
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rukiye GONEN OZDEMIR
Kırıkkale University, Faculty of Medicine, Department of Cardiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place