Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels (NCT03310450), a registered phase not stated study. The primary outcome is Cardiac Troponin I (cTnI).

2. Clinical Question

The registry describes a prospective observational study, not a trial in which investigators assigned a treatment. Its stated purpose concerns relationships among cycling, cTnI, MDA, and hs-CRP. The record also lists hs-CRP and pathological ECG appearance among secondary outcomes. The association questions are clinically and statistically distinct: measuring a biomarker after an event describes a response, while identifying a predictor requires analysis of how measured factors relate to that response. The registry record does not report those analyses, the participant-level measurements, or estimates of association. Consequently, the question can be described from the stated aims, but the strength, direction, and precision of any relationships cannot be assessed from this record.

3. Trial Design

This is a prospective observational study of participants taking part in cycling touring events. The status is COMPLETED. The record gives a start date of 2017-10-28 and a primary completion date of 2017-11-11, and identifies Universitas Negeri Semarang as the sponsor. Enrollment is recorded as 94.

The groups are described by event and distance: Tour de Borobudur 2017 140kms cycling, Tour de Borobudur 2017 100kms cycling, and North Coast 2017 240kms cycling. The descriptions state that participants were willing to participate and that investigators did not give an intervention, but observed the cycling touring event. The registry nevertheless lists 140kms cycling under interventions; that label should be read alongside the explicit descriptions of observational conduct.

Because participants took part in different events and distances, the groups do not constitute a randomized, like-for-like control comparison. Participants may differ in ways not described in the record, and event context is also not separated from distance. No allocation method is stated. The registry specifically flags that this is not a randomized comparison and that the arms are not a like-for-like control comparison. This limits causal interpretation of any between-group contrast.

The primary outcome is cTnI, recorded as a mean with standard deviation and measured immediately after TdB 2017 cycling touring within less than 5 min. The record also lists hs-CRP and the number of participants with pathological ECG appearance as secondary outcomes, and describes the study aim as involving MDA as well. It reports four outcome measures, but outcome estimates and the three other measure details are not reported in the registry record. The record lists no analyses. Its statistical analysis plan, missing-data approach, and sample-size justification are not reported in 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: Participants with a history of coronary artery diseases (CAD) were excluded from study participation. Subsequently, a total of 94 participants were included in this study

Overall Study

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.

Population: 30 participants completed Tour de Borobudur 140K, 2017 30 participants completed Tour de Borobudur 100K, 2017 28 participantas completed North Coast Tour, 2017

6. Primary Endpoint

The registry lists the primary outcome as Cardiac Troponin I (cTnI), measured over immediate after TdB 2017 cycling touring within less than 5 min.

The primary endpoint is cardiac troponin I (cTnI), measured as a continuous quantity and summarized in the record as a mean with standard deviation. The registry gives the unit as ng/dL and specifies measurement immediately after Tour de Borobudur 2017 cycling touring within less than 5 min. It describes cTnI as a specific protein to determine cardiac injury.

As a general statistical point, a continuous endpoint preserves information about the measured level rather than reducing participants to categories. A mean describes the central level in a group, while a standard deviation describes the spread of individual measurements around that mean. These summaries can help readers understand both the average measurement and how much participants’ measurements vary. They do not, on their own, explain why values differ or establish that cycling caused a change.

The timing is important to interpretation because the registered measurement is an immediate post-event measure, not a measure collected at an unspecified later time. The record does not state a pre-event cTnI measurement, a change-from-baseline endpoint, a threshold defining an elevated value, or a reference range. It also does not provide any cTnI group means or standard deviations. The endpoint’s measurement method and the handling of values outside any assay range are not reported in the registry record. Without the actual results and additional measurement details, the endpoint definition can be described, but the magnitude and precision of cTnI values cannot be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The record gives a limited account of the intended measurement and design, but it does not report a statistical analysis plan. The methods concepts below explain how the stated outcome type is usually read in general; they do not describe analyses confirmed to have been performed for this study.

What does a mean and standard deviation convey?

For a continuous outcome such as cTnI, a mean is an average measurement. The standard deviation describes how dispersed measurements are around that average. In general, the mean and standard deviation are useful together: a mean alone can conceal whether observations cluster near the average or vary widely. These summaries do not show the full distribution, identify unusual observations, or explain sources of variation. A mean and standard deviation are also not the same as a confidence interval. The former describe measurements in a group; the latter, when calculated, describe uncertainty in an estimated quantity under a statistical procedure.

The registry specifies mean and standard deviation as the summary format for the primary endpoint, but does not report their values. It also does not state whether the distribution was checked, whether transformations or robust summaries were considered, or how the measurement was handled in any model. Those details are not reported in the registry record.

What does an observational comparison mean?

In a randomized study, random allocation is intended to balance measured and unmeasured characteristics across groups on average. This study is described as observational, with investigators observing tours rather than assigning the activity. The registry explicitly notes that this is not a randomized comparison and that the groups are not a like-for-like control comparison. As a general principle, a group contrast in an observational study can reflect differences in participant characteristics, event conditions, or other factors as well as the exposure under study. Statistical adjustment may address measured factors if they are collected and modeled appropriately, but cannot guarantee removal of unmeasured confounding.

Here the listed groups also combine distance with event: the 100kms and 140kms tours are part of Tour de Borobudur 2017, whereas the 240kms tour is associated with North Coast 2017. The registry does not report an analysis separating these features. Therefore, the design alone does not support attributing a hypothetical contrast solely to distance.

How should uncertainty be assessed?

General statistical interpretation considers an estimate together with its uncertainty, rather than relying only on whether a test crosses a significance threshold. A confidence interval can communicate both the range of estimates compatible with the data and the precision of the result. A narrow interval generally indicates greater precision than a wide interval, although interpretation also depends on the outcome and study design. A p-value, if reported, addresses compatibility with a specified null model and is not a measure of effect size or clinical importance. This registry record reports no confidence intervals, p-values, or primary outcome estimates, so neither precision nor statistical evidence can be assessed.

For predictor analyses, estimates would depend on how predictors and the outcome were defined, which covariates were included, and how the model was specified. The record mentions MDA and hs-CRP in the study aim, but does not report predictor estimates, model details, or the handling of correlated predictors. These analytic choices are not reported in the registry record.

What does the sample-size illustration represent?

The record describes a planning illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that such figures are participants per arm for 80% or 90% power, depending on the planning scenario. These calculations are illustrations for future planning, not observed power and not evidence about the likelihood that this completed study detected an effect. The registry does not report the study’s own design justification or state that these assumptions governed enrollment.

In general, power calculations depend on an assumed effect, outcome variability, significance level, allocation, and analysis method. If the assumed effect is drawn from an observed estimate, the planning result remains conditional on that estimate and its uncertainty. A sample-size calculation cannot substitute for reporting the observed estimate and confidence interval. No specific calculated planning values are included in the registry record.

What analytic details are unavailable?

The record lists zero analyses. It does not state whether an interim analysis was planned or conducted, how missing measurements were handled, which participants were included in each analysis, or whether any multiplicity adjustment was planned. It also does not identify the statistical tests or model used for the primary endpoint. These absences mean that the intended endpoint is identifiable, but the analytic route from participant measurements to any reported conclusion is not documented in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Group 140kms Cycling", "Group 100kms Cycling", "Group 240kms Cycling")
n   <- c(30, 30, 28)
m   <- c(6.6, 10.1, 25)
sp  <- c(46.6, 10.44, 61.39)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Group 140kms Cycling  30  6.600  46.600  -10.801  24.001
CARM  Group 100kms Cycling  30  10.100  10.440  6.202  13.998
CARM  Group 240kms Cycling  28  25.000  61.390  1.195  48.805

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, with cTnI identified as primary and hs-CRP and pathological ECG appearance identified among the secondary outcomes. The study aim also refers to MDA. When a study examines multiple outcomes, predictors, or comparisons, the chance of at least one apparently notable result can increase if each is tested separately without accounting for the family of analyses. As a general statistical approach, investigators may define a primary analysis in advance, adjust for multiplicity, or treat additional analyses as exploratory. Which approach was used in this study is not reported in the registry record.

The record lists zero analyses and does not report outcome estimates, p-values, confidence intervals, or any multiplicity procedure. It is therefore not possible to tell whether there were planned comparisons, how they were prioritized, or how any multiplicity was handled. The listed sample-size illustration does not resolve this issue; it is described as a planning calculation rather than the study’s own design justification.

Missing-data handling and analysis populations are also not described. The registry does not state the number of participants with an observed cTnI measurement, whether all enrolled participants contributed to each endpoint, or how unavailable or unusable measurements were treated. Nor does it specify an intention-to-treat population, a per-protocol population, or an alternative analysis set. In a general sense, missingness can affect both the amount of information and the validity of comparisons if the reasons for missing measurements are related to participant characteristics or outcomes. Without counts and methods, the extent and potential impact of missing data cannot be assessed.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry’s adverse-event entries report zero serious adverse events and zero deaths for each of the three listed cycling groups. The entries also show zero participants affected by other adverse events in each group. These are registry-reported counts, not estimates of comparative risk.

The record lists 30 at risk in the 140kms group, 30 at risk in the 100kms group, and 28 at risk in the 240kms group for the adverse-event reporting. These group-specific entries should not be combined or treated as the cTnI analysis sample sizes. The registry does not provide details about the method or period used to collect adverse events, event definitions, or whether all participants were monitored in the same way.

Zero reported events do not establish that an event is impossible or that no event occurred outside the reporting process. They describe what the registry records for the stated categories. Because this was observational and the groups are not like-for-like controls, these figures should not be interpreted as a randomized safety comparison. The record does not report event narratives or a separate safety analysis.

13. What the Result Does, and Does Not, Mean

The record is useful for identifying the study’s observational question, the cycling groups, the primary endpoint, and the timing of measurement. It documents an aim to examine predictors related to cTnI release, MDA, and hs-CRP after cycling. It also records cTnI as a mean continuous endpoint measured immediately after Tour de Borobudur 2017 cycling touring within less than 5 min, and names hs-CRP and pathological ECG appearance among the secondary outcomes.

It does not, however, provide the results needed to answer whether cTnI differed by group, how much it varied, or whether MDA or hs-CRP predicted cTnI release. The record reports no outcome estimates or statistical analyses. It therefore cannot establish the magnitude or direction of any association, the precision of an estimate, or whether an observed finding would be compatible with chance under a chosen statistical model.

Even if a group comparison were available, the observational design and non-equivalent groups would limit causal claims. Participation was observed rather than assigned, and event and distance differ across groups. General considerations such as participant characteristics and event conditions could influence measurements, but the record does not describe these factors or any adjustment strategy. A between-group contrast would not automatically represent an effect caused by cycling distance.

The reported adverse-event counts describe registry entries, not comprehensive proof of safety. The absence of recorded serious events and deaths should be read as zero reported in these categories, not as evidence that risk is absent. Similarly, COMPLETED status confirms the record’s status but does not supply missing outcome results. The study’s registered purpose can be understood; its empirical findings and their certainty cannot be determined from the registry record.

14. Why This Trial Matters Statistically

This study is statistically notable because its question concerns biomarker measurements after real-world cycling events rather than an investigator-assigned treatment. That makes clear separation between description, association, and causation especially important. A measured post-event cTnI value can describe the outcome at a specified time, while a claim that a factor predicts that value requires an analysis linking the factor and outcome. A causal claim would require stronger support than an unadjusted difference between groups that took part in different events.

The registered endpoint definition provides a useful starting point: cTnI is measured immediately after Tour de Borobudur 2017 cycling touring within less than 5 min and is summarized as a mean with standard deviation. But statistical interpretation also depends on the actual values, participant-level completeness, uncertainty, and analytic method. None of those results is reported in the registry record. The stated aims involving MDA and hs-CRP highlight the importance of defining which associations are primary and how multiple outcomes are handled, yet the analysis strategy is not documented.

The record also illustrates why enrollment and results should not be conflated. Enrollment is recorded as 94, while the number contributing to any biomarker analysis is not reported. Adverse-event risk counts are specific to their reporting entries and do not supply outcome-specific analysis denominators. Without results by endpoint, neither precision nor representativeness can be evaluated.

The study’s design and stated questions remain interpretable even though its results are absent from this registry record. The distinction is central for clinical research: a completed study record can document what was intended and how groups were described without enabling readers to assess findings. Statistical transparency requires outcome estimates and their uncertainty as well as a clear account of analysis populations and methods.

15. 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.

Important limitations arise from the information recorded for this study. First, the registry does not report the primary endpoint values, variability, confidence intervals, or analyses. This prevents assessment of the size and precision of cTnI measurements and means that the stated predictor question cannot be evaluated from the record.

Second, the study is observational, and the registry states that the groups are not a like-for-like control comparison. The groups also combine different distances with different events: Tour de Borobudur 2017 is associated with the 100kms and 140kms groups, while North Coast 2017 is associated with the 240kms group. Any hypothetical differences could reflect these or other factors, not distance alone. The record does not describe participant characteristics or adjustment for potential confounders.

Third, the endpoint is an immediate post-event cTnI measurement, but the registry does not report a baseline measure, later follow-up, assay details, or a threshold for interpreting the measurement. The stated timeframe therefore limits the outcome to an immediate post-event assessment; broader patterns cannot be inferred from it.

Fourth, the analysis population and missing-data approach are not reported. Although enrollment is recorded as 94, the number with measurements available for each outcome and the handling of missing or unusable data are not stated. The record also lists zero analyses and does not provide a statistical plan, multiplicity procedure, or sample-size justification for the study itself. These omissions limit reproducibility and evaluation of bias or precision.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels — NCT03310450.
• Registry record last updated 2019-10-10; status last verified 2019-10.
• Results first posted 2019-10-02.
• 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.

19. Record Summary

NCT03310450 is a completed prospective observational study sponsored by Universitas Negeri Semarang. The record lists enrollment as 94, a start date of 2017-10-28, and a primary completion date of 2017-11-11.

The study aim concerns predictors related to cTnI release, MDA, and hs-CRP after cycling. The primary outcome is mean cTnI in ng/dL, measured immediately after Tour de Borobudur 2017 cycling touring within less than 5 min. The groups are described as Tour de Borobudur 2017 100kms and 140kms cycling, and North Coast 2017 240kms cycling. Investigators are described as observing the events without giving an intervention.

The registry identifies hs-CRP and pathological ECG appearance among the secondary outcomes. It reports no analyses or outcome estimates. The group comparisons are not randomized or like-for-like, and the statistical analysis plan, missing-data methods, and study-specific sample-size justification are not reported in the registry record.