This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Association Between SYNTAX Score and Leukoglycemic Index In Patients Wiht Acute Coronary Syndrome (NCT07276256), a registered phase not stated study. The primary outcome is Leukoglycemic Index (LGI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT07276256 |
| Phase | Phase not stated |
| Condition | Acute Coronary Syndromes (ACS) |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 552 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Kırıkkale University |
| Results posted | Yes |
2. Clinical Question
Population
People presenting to hospital with acute coronary syndrome (ACS). The registry summary says investigators use routine blood tests taken on arrival and information from patient records and medical interviews. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
There is no treatment intervention described. Investigators calculate the leukoglycemic index (LGI) from blood glucose concentration and leukocyte count, using their product as a combined measure. The calculation is a study measure, not a treatment assigned to participants.
Comparator
The comparison is between groups defined by SYNTAX score: 22 or less, and above 22. These are categories of coronary disease complexity, not randomized treatment arms. The registry record does not describe a separate control intervention.
Primary question
Is LGI associated with the complexity of coronary artery disease, as represented by the SYNTAX score grouping? The record also states that investigators intend to assess whether LGI can help predict disease complexity. Numerical estimates of association, predictive performance, and uncertainty are not reported in the registry record.
The question is observational: it concerns whether a blood-based measure varies with a disease-complexity measure among people with ACS. It does not test whether changing LGI changes coronary disease, nor does it compare assigned treatments. The clinical and statistical interpretation therefore depends on the relationship between the recorded LGI values and SYNTAX scores, along with how those measures were collected and analyzed. Details of the scoring process, the timing of SYNTAX assessment, and any adjustment for participant characteristics are not reported in the registry record.
3. Trial Design
The registry describes an observational study of people presenting to hospital with acute coronary syndrome. The record lists Kırıkkale University as sponsor, an enrollment of 552, and a status of completed. The recorded study start is 2025-09-24, and the primary completion date is 2025-10-21. The primary measure is LGI on the first day.
Participants are classified according to SYNTAX score, with one group at 22 or less and the other above 22. The score is used to represent the complexity of coronary artery disease. The study summary says investigators compare health data across these score-defined groups and examine whether LGI is linked to disease severity or can help predict complexity. The registry classifies the study as other, rather than as a randomized comparison. Allocation is not stated, and the groups are not a like-for-like control comparison: they are formed from a disease-complexity measure.
The only listed intervention is calculation of LGI, categorized as other. That describes a measurement procedure, not an assigned therapy. No treatment schedule, randomization process, masking procedure, or prospective follow-up plan is reported in the registry record. The registry record also does not report detailed eligibility criteria, recruitment procedures, the number of participants in each score group, or whether all enrolled participants contributed to the primary measure.
The record lists one primary outcome measure but no analysis results. It does not give numerical summaries for either group, an association estimate, or a prediction-performance estimate. Thus, the design and intended comparison can be described, but the strength and precision of any observed relationship cannot be assessed from the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 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
Overall Study
| Stage | SYNTAX Score =<22 | SYNTAX Score >22 |
|---|---|---|
| STARTED | 400 | 152 |
| COMPLETED | 400 | 152 |
| NOT COMPLETED | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | SYNTAX Score =<22 | SYNTAX Score >22 | Total |
|---|---|---|---|---|
| Participants analysed | 400 | 152 | 552 | |
| Age, Continuous | years | 58.6 (SD 12.7) | 63.6 (SD 14.1) | 60.1 (SD 13.3) |
| Sex: Female, Male: Female | Participants | 84 | 34 | 118 |
| Sex: Female, Male: Male | Participants | 316 | 118 | 434 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Leucoglycemic Index (LGI) | mg/dL*cells per mm^3 | 1.081 (0.830 to 1.410) | 1.230 (0.825 to 1.743) | 1.089 (0.825 to 1.743) |
6. Primary Endpoint
The registry lists the primary outcome as Leukoglycemic Index (LGI), measured over First day.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | mg/dL*cells per mm^3 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the leukoglycemic index (LGI), reported as a median with full range for the first day. The record defines LGI as the product of blood glucose concentration, in mg/dL, and leukocyte count, in cells per mm³. Its stated unit is mg/dL*cells per mm^3. It combines a measure of blood sugar with a measure of white blood cells into one value.
As a general statistical concept, a composite measure can condense information from multiple measurements into a single summary. Here, the stated rationale is to represent metabolic and hematological status together. The registry description characterizes higher LGI values as worse because they reflect greater metabolic and inflammatory burden. This is the record’s framing of the measure; it does not establish that the index itself causes disease complexity or predicts outcomes accurately.
The registry record does not report the median or full range for either SYNTAX-defined group. It also does not provide the precise blood sampling protocol, laboratory methods, or handling of values that might be missing or outside a measurement range. Without those details and the numerical endpoint results, the magnitude and precision of any between-group pattern cannot be evaluated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clear intended association question: whether LGI is related to coronary disease complexity among people with ACS. It defines the primary measure and the score-based groups, but does not report numerical LGI summaries or statistical analysis results. Consequently, the posted results do not establish whether LGI values differed between the groups, how large any difference might have been, or how uncertain an estimate would be.
The planned endpoint summary is a median and full range. As a general statistical explanation, the median describes the center of a distribution without being as sensitive to extreme observations as the arithmetic mean. The full range reports the lowest and highest observed values, but by itself gives limited information about how values are distributed between those extremes. The record does not include the actual summaries, so neither the central values nor the spread can be interpreted.
The two groups are defined by SYNTAX score, a measure of disease complexity, rather than by random assignment. Any observed relationship would therefore be an association, not evidence that LGI causes greater complexity or that changing LGI would alter the SYNTAX score. Other characteristics could be associated with both the blood measurements and disease complexity. The summary mentions collection of age, family history, and chronic illnesses, but the registry record does not report whether these characteristics were included in an adjusted analysis.
The registry record lists no statistical analyses and provides no inferential estimates. There is no reported confidence interval, p-value, predictive-performance measure, or model specification. A confidence interval, as a general concept, expresses a range of values compatible with the data and the assumptions of an analysis; without one, the precision of an estimate cannot be assessed. Similarly, a p-value cannot describe the size or clinical importance of an association, and none is reported for this endpoint.
The record is marked completed, but completion status does not substitute for outcome reporting. Enrollment is recorded as 552, but that is not a reported analysis sample size and should not be interpreted as the number contributing to the endpoint. Group-specific enrollment, exclusions, missing endpoint values, and analysis populations are not reported in the registry record. The defensible interpretation is therefore limited to the study’s objective and measurement plan, not the presence, size, or reliability of a finding.
9. Statistical Methods Explained
The registry record describes an observational comparison organized around SYNTAX score categories. This makes the statistical question one of association: whether an LGI measurement is related to a marker of coronary disease complexity. It is not a randomized treatment comparison. Because the groups are defined by the score itself, contrasts between them describe differences across categories; they do not isolate the effect of an intervention.
What does the primary measure represent?
LGI is defined as blood glucose concentration multiplied by leukocyte count. The registry gives the unit as mg/dL*cells per mm^3 and identifies the first day as the timeframe. In general, combining measurements can yield a compact summary, but it also means the resulting value reflects both components. An association with LGI alone would not show whether the glucose component, leukocyte component, or both accounted for the pattern. Component-specific results are not reported in the registry record.
Why report a median and full range?
The endpoint is specified as a median with full range. As general statistical context, the median is the middle of ordered observations and can be useful when a measure is skewed or has extreme values. The full range communicates the observed endpoints of the distribution. It can be sensitive to unusual observations and does not show the density of values between the minimum and maximum. Other distribution summaries, such as quartiles, are not reported in the registry record.
To compare score-defined groups, an analysis could describe the LGI distributions separately and estimate a contrast or association. That is a general description of possible methods, not a claim about the analysis performed. The registry record contains no analysis results or details of a statistical test, model, transformation, or adjustment set. It is therefore not possible to determine whether the investigators compared medians directly, modeled LGI as a continuous measure, or used another approach.
What would an association estimate mean?
In general, an estimate summarizes the direction and size of a relationship in the analyzed data. Its interpretation depends on how both variables are represented. Comparing two score categories addresses a different question from relating LGI to the full score scale. The registry summary identifies the categories but does not report whether the continuous SYNTAX score was also analyzed. It also does not state how the score was assessed or whether its measurement was blinded to LGI.
A confidence interval is a general tool for describing statistical uncertainty around an estimate under the assumptions of the chosen method. Narrower intervals generally indicate greater precision, while wider intervals indicate less precision. The registry record reports no confidence interval or other uncertainty interval for the primary endpoint. No p-value is reported either. Even if a p-value were available, it would not by itself indicate the size, clinical relevance, or predictive usefulness of an association.
What is needed to interpret prediction?
The study summary says investigators will check whether LGI can help predict disease complexity. Prediction is a distinct question from association. A measure may be associated with an outcome yet still provide limited individual-level predictive information. As general statistical practice, assessing prediction typically requires a defined prediction target, a specified model, and measures of predictive performance; evaluation in data separate from model development can also help assess how well performance carries beyond the data used to fit a model. The registry record does not report a prediction model, a performance measure, or a validation approach. No predictive conclusion can therefore be drawn from the record.
Why might adjustment and data distribution matter?
The summary says age, family history, and chronic illnesses are collected. In an observational analysis, adjustment for relevant characteristics may help address differences between groups, but adjustment cannot guarantee removal of confounding. The registry record does not specify which variables were included in any model, how they were selected, or how missing covariate values were handled.
As general statistical context, an index formed from biological measurements may have a skewed distribution or unusually large values. A method that assumes normally distributed errors may be sensitive to such features. Over-dispersion, broadly, means that observed variability exceeds what a particular model assumes; if present, it can make standard errors and uncertainty estimates unreliable unless the method accounts for it. The record does not report distributional checks or a model that would allow these issues to be assessed.
Enrollment is recorded as 552, but the analysis sample and group-specific counts are not reported. A planning illustration based on an observed effect is not observed power; it describes assumptions for a hypothetical design rather than the precision or success of the completed analysis. The registry record does not provide numerical planning estimates or the trial’s own sample-size justification. Details of interim analyses and the statistical plan are also not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary outcome measure and no statistical analyses. It does not report whether investigators examined additional outcomes, multiple versions of the LGI measure, subgroups, or alternative models. A multiplicity strategy, such as a prespecified hierarchy or adjustment for multiple testing, is not reported in the registry record. Without an analysis plan and reported results, it is not possible to assess whether multiplicity affected interpretation.
Missing-data methods are not reported. The record does not state whether LGI or SYNTAX score values were missing, how many observations contributed to each analysis, or whether any imputation or other missing-data procedure was used. Enrollment of 552 is not equivalent to a reported endpoint analysis sample, and the record does not provide group-specific denominators.
The analysis population is also not defined in the posted results. It is not reported whether analyses included all enrolled participants, only those with both measures available, or another subset. Eligibility criteria, exclusions after enrollment, and handling of incomplete records are not reported in the registry record.
These omissions matter because both selective analyses and missing data can affect the apparent relationship between LGI and disease complexity. This is a general methodological concern, not evidence that either issue occurred in this study. The record does not provide enough information to evaluate their impact or to reproduce an analysis.
11. What the Result Does, and Does Not, Mean
The registry record describes a completed study intended to examine whether LGI is associated with coronary disease complexity among people with ACS. It defines LGI as the product of blood glucose concentration and leukocyte count, and divides participants according to SYNTAX score at 22. These details establish the intended measurement and comparison, but they are not a reported finding about the relationship.
No numerical primary endpoint summaries or statistical analyses are reported. The record therefore does not show whether LGI was higher in either score group, whether an association was observed, or how precisely an association was estimated. It also does not report predictive performance. Completion status and enrollment do not fill these gaps.
Even if a relationship were reported, an observational association would not establish that LGI causes coronary disease complexity. The score-based groups are not randomized treatment arms, and differences between them could reflect other participant characteristics. The summary mentions age, family history, and chronic illnesses, but does not state whether analyses accounted for these factors.
In general, a single combined index can be informative as a compact measure while obscuring which component contributes to a pattern. The registry record does not report separate analyses of blood glucose and leukocyte count. Nor does it report whether the index improves prediction beyond other available information.
The available information supports a description of the study’s aim, measure, and design category. It does not support a conclusion about the direction, magnitude, statistical significance, or practical predictive value of the association. Those conclusions require endpoint results and analysis details that are not reported in the registry record.
12. Why This Trial Matters Statistically
This study raises a useful statistical question about how a combined blood-based measure relates to a measure of coronary disease complexity in people with ACS. LGI combines glucose concentration and leukocyte count, while SYNTAX score is used to classify disease complexity. Studying how these measures relate may be of interest to researchers assessing whether routine measurements carry information about disease characteristics.
The main statistical distinction is between association and prediction. An association describes how measurements vary together in observed data. Prediction asks whether a measure can accurately distinguish or estimate an outcome for individuals. As a general principle, evidence of association alone does not establish useful predictive performance. The registry summary identifies both aims, but does not report analyses that would answer either question.
The observational design is also important. The score groups are not randomized treatment arms, so comparisons between them cannot be interpreted as effects of an assigned intervention. Confounding and measurement choices can shape observed patterns, and a clear account of analysis methods is needed to evaluate those issues.
The record’s limited outcome reporting makes the study statistically notable for the gap between a defined question and an assessable result. It records a completed study, the intended first-day LGI measure, and the score thresholds, but no numerical endpoint summaries or inferential results. Without those results, readers cannot judge the size or precision of a relationship or the performance of any prediction approach.
13. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation of the registry record is that it does not report numerical primary endpoint results or statistical analyses. The median and full range are specified as the endpoint summary, but values for either SYNTAX-defined group are absent. No estimate of association, uncertainty interval, or p-value is reported. This prevents assessment of the result’s direction, magnitude, and precision.
Although enrollment is recorded as 552, the record does not report how many participants had usable LGI and SYNTAX measurements, the size of either score group, or the analysis population. Missing-data frequency and handling are not reported. The study summary mentions age, family history, and chronic illnesses, but adjustment for these factors is not described.
The record does not provide detailed eligibility criteria, recruitment procedures, or the procedures used to measure glucose, leukocyte count, and SYNTAX score. It does not report whether the continuous score was analyzed in addition to the score categories, or whether the analysis assessed the separate components of LGI. Prediction methods and validation results are also not reported.
The study is observational, and the groups are defined by disease-complexity score rather than randomization. As a general limitation of observational comparisons, unmeasured or inadequately measured characteristics may influence an observed relationship. This does not establish that confounding occurred in this study, but the record does not report enough analysis detail to evaluate it. The sample-size justification, statistical plan, and interim-analysis details are not reported in the registry record.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Association Between SYNTAX Score and Leukoglycemic Index In Patients Wiht Acute Coronary Syndrome — NCT07276256.
- Registry record last updated 2026-02-25; status last verified 2025-12.
- Results first posted 2026-02-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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17. Record Summary
The registry record identifies NCT07276256 as a completed study sponsored by Kırıkkale University. It records an enrollment of 552, a start date of 2025-09-24, and a primary completion date of 2025-10-21. The study concerns acute coronary syndromes and examines the relationship between leukoglycemic index and coronary disease complexity.
The primary endpoint is LGI, defined as blood glucose concentration multiplied by leukocyte count, summarized as a median with full range for the first day. Participants are categorized by SYNTAX score at 22: one group at 22 or less and another above 22. The design is not described as randomized, and the allocation method is not stated.
Numerical endpoint results, statistical analyses, missing-data methods, and prediction-performance results are not reported in the registry record. The record therefore describes the study question and measurement plan but does not permit evaluation of the observed association.