Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery (NCT02870933), a randomized phase 4 study. The primary outcome is Myocardial Defect Perfusion.

2. Clinical Question

3. Trial Design

The registry identifies NCT02870933 as a phase 4, randomized, parallel-group trial with no masking. The listed enrollment is 30. The study is marked completed. Its start is recorded as 2016-01 and its primary completion as 2018-04. The sponsor is National Cardiovascular Center Harapan Kita Hospital Indonesia.

The study compared transepicardial with transseptal autologous CD 133+ bone marrow cell implantation against a control arm that did not receive that implantation. The brief summary places the intervention during CABG. The record does not provide the randomization procedure, allocation ratio, concealment method, or details about how the cell preparation and implantation were performed. It also does not describe other care received in either arm.

No masking is recorded. This means the registry does not describe the trial as blinded, but it does not specify which people involved in care, outcome assessment, or analysis knew the assigned group. Those roles and any safeguards against assessment bias are not reported in the registry record.

The stated primary outcome was myocardial defect perfusion, assessed at baseline and six months. The registry lists a mean and standard deviation as the outcome summary and describes the measure as the number of heart-wall segments with a perfusion defect measured by MRI. The unit is recorded as percentage of myocardial perfusion. Because these descriptions do not fully explain how the segment count was converted or expressed as a percentage, the operational calculation is not clear from the record.

Other listed outcomes include the Six Minutes Walking Test, Wall Motion Score Index, Myocardial Scar Size, Vascular Endothelial Growth Factor, Left Ventricle End Systolic Volume, Minnesota Living With Heart Failure Questionnaire, and Left Ventricle End Diastolic Volume. The record lists nine outcome measures overall, but does not report numerical findings for these measures. Detailed study dates beyond the recorded month and year, recruitment procedures, and participant flow 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.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Myocardial Defect Perfusion, measured over Baseline, 6 months.

The primary endpoint is called myocardial defect perfusion. The registry describes it as the number of heart-wall segments with a perfusion defect measured by MRI, and lists percentage of myocardial perfusion as its unit. It specifies a mean and standard deviation and names baseline and six months as assessment times. The record does not define the MRI reading procedure, the scale's possible range, the threshold for classifying a segment as defective, or the calculation connecting the segment count to the percentage unit. These details are needed to interpret the measurement precisely.

As a general concept, a perfusion measure is intended to characterize how well blood reaches heart muscle. An imaging-based measure can describe a structural or functional feature of the heart, while a patient-reported measure or walking test describes a different aspect of health. These measures answer related but non-identical questions; results from one cannot substitute for results from another.

Baseline and follow-up assessments can describe change over time, and comparison between randomized groups can help distinguish a treatment-associated pattern from changes shared by both groups. But interpreting such a comparison requires the actual group results, the method used to analyze repeated measurements, and a clear definition of the measurement. The registry record does not report the primary endpoint values at either assessment or an estimated between-group effect. Therefore, the endpoint's intended role can be described, but the size and precision of any observed difference cannot be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization is a design method that assigns participants to groups by chance. In general, its purpose is to make the groups comparable with respect to both measured and unmeasured characteristics at the time of assignment. It does not ensure exact balance in every realized trial, and it cannot prevent bias caused by later exclusions, missing outcomes, differences in care, or outcome measurement. The registry identifies this trial as randomized but does not report how the random sequence was generated, how assignments were concealed, or how participants entered the analysis.

What does the parallel-group design mean?

In a parallel-group design, participants are assigned to one group and followed in that group, rather than switching between interventions. The record describes a cell-implantation arm and a control arm without that implantation. This design supports a between-group comparison, but the treatment contrast is fully interpretable only when the other care, follow-up, and analysis procedures are also understood. Those details are not reported in the registry record.

How should baseline and follow-up measurements be understood?

The primary outcome is scheduled at baseline and six months. In general, baseline values describe the measure before follow-up, while the later measurement describes the outcome at follow-up. Researchers can compare the groups at follow-up, compare changes from baseline, or use a model that includes both time points. These are distinct analysis choices. The registry record does not state which approach was used, whether baseline values were adjusted for, or how repeated measurements were handled.

The endpoint is classified as continuous and summarized using a mean and standard deviation. In general, a mean describes the average value, while a standard deviation describes the spread of participant values around that average. This summary can be useful when the measurement has an interpretable numerical scale and its distribution is adequately represented by the mean and standard deviation. The underlying values, distribution, and analysis details are not reported, so the suitability of that summary cannot be assessed.

What does a confidence interval contribute?

As a general statistical concept, a confidence interval expresses uncertainty around an estimated effect. It helps readers judge both the range of effect sizes compatible with the data and the precision of the estimate. A confidence interval does not by itself establish whether an effect is important, and its interpretation depends on the design, analysis, and assumptions. The registry record does not report a confidence interval for the primary comparison, so its precision cannot be evaluated.

What are p-values and significance thresholds?

In general, a p-value describes how incompatible the observed data are with a specified statistical model that assumes no effect, under that model's assumptions. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of an effect. A significance threshold is a decision convention used in some testing procedures. The record does not report a primary p-value or a statistical analysis plan, so no conclusion about statistical significance can be drawn.

Why can over-dispersion matter?

As a general explanation, over-dispersion occurs when the observed variation in data is greater than a model assumes. If a method assumes less variability than is present, its uncertainty estimates can be too small and statistical tests can appear more decisive than warranted. Methods that account for extra variation may be appropriate in some settings. This trial's primary endpoint is listed as a continuous measure summarized by a mean and standard deviation, and the record does not report an over-dispersion assessment or a model specification. There is therefore no basis to state whether over-dispersion was relevant or how it was addressed.

What do the planning assumptions mean?

The registry's planning description refers to an illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These are assumptions for a planning illustration, not a statement that the original trial was designed using those assumptions. The record does not report the resulting planning values or the fraction used in each illustration.

In general, a sample-size illustration estimates the number of participants per arm that might be needed under specified assumptions about the effect, variability, significance level, allocation, and statistical method. Its result changes when those assumptions change. A calculation based on an observed effect is especially dependent on the estimate used: an uncertain or unusually large observed effect can make planning estimates unstable. Such illustrations are not observed power and do not establish that a completed trial had adequate power. The original sample-size justification and design assumptions are not reported in the registry record.

The primary outcome has multiple assessment times, and the registry's note indicates that it was not reduced to a single comparison. This means the record does not identify one selected contrast for interpretation. How outcomes across times were combined or prioritized, and whether the analysis accounted for their correlation, are not reported. Without the analysis details and numerical estimates, the design can be described, but its inferential results cannot be reconstructed.

10. Multiplicity, Missing Data and Analysis Populations

The registry describes a primary endpoint at baseline and six months and lists multiple additional outcomes. Whenever more than one endpoint, time point, subgroup, or statistical comparison is examined, the chance of obtaining at least one apparently unusual result can increase. As a general statistical principle, a prespecified testing hierarchy or an adjustment for multiple comparisons can help address this issue. Such methods may also affect the precision or interpretation of individual comparisons.

The registry record does not report a multiplicity strategy, a hierarchy among outcomes or time points, or which comparisons were designated for formal testing. It also does not report an analysis plan specifying how the baseline and six-month measurements were to be used. The primary outcome is not reduced to one comparison in the record, so there is no single reported contrast to interpret as the definitive primary estimate.

Missing-data handling is not reported. The record does not give the number of participants with outcome measurements at each time, reasons for missing measurements, or the method used to handle missing values. These matters can affect estimates, particularly if the chance of a missing measurement is related to a participant's outcome or assigned group.

The analysis population is also not described. The record does not state whether participants were analyzed according to randomized assignment, whether any participants were excluded after assignment, or whether other analysis populations were used. Although enrollment is listed, that information alone does not establish how many participants contributed to each outcome analysis. The number of analyses reported in the registry is 0; this does not identify what analyses may have been performed outside the registry, but it means the registry record does not provide analysis results.

11. 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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: sepsis (7.7%), haemodynamic instability (7.7%).

The registry lists serious adverse events for the Subject and Control groups. For the Subject group, 2 serious adverse events are reported among 13 at risk; for the Control group, 1 is reported among 13 at risk. The record separately lists 2 deaths for the Subject group and 1 for the Control group. It does not state whether deaths were included in the serious-event counts, whether events were judged related to the intervention, or when they occurred.

The record lists Sepsis and Haemodynamic instability as the top serious-event terms, each with a reported value of 7.7%. It does not specify in this summary how the terms map to groups or whether an individual could have more than one event or term. These percentages should therefore be read as registry-reported event information, not as a complete account of event timing, severity, attribution, or participant-level risk.

Other adverse events are recorded as 0 among 13 at risk in each group. This is a statement about the registry's reported count for that category; it does not establish that no other event of any kind occurred. The record does not describe adverse-event collection procedures, definitions, follow-up duration for safety, or missing safety information. These small-group counts are descriptive and do not, on their own, establish a difference in safety between groups.

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

The registry record documents a randomized comparison of transepicardial with transseptal autologous CD 133+ bone marrow cell implantation against no such implantation, in the setting of CABG. It specifies myocardial defect perfusion as the primary outcome and identifies baseline and six months as assessment times. These details establish the study's topic and intended measurement, but they are not outcome evidence by themselves.

The record does not report numerical primary-endpoint results, a between-group estimate, an uncertainty interval, or a p-value. As a result, it does not show whether perfusion values changed, how the two groups compared, or how precise any estimated difference was. No conclusion about the direction, magnitude, or statistical significance of the primary result can be drawn from the registry information.

Even when outcome data are available, statistical evidence and clinical importance are different questions. An estimate may be precise but small, or potentially important but too imprecise to distinguish from other possibilities. In general, interpretation requires the effect estimate, its uncertainty, the measurement scale, and relevant clinical context. The registry does not report enough primary outcome information to make those judgments.

The listed secondary outcomes cover walking performance, heart-wall motion, scar size, a vascular growth factor, ventricular volumes, and a heart-failure questionnaire. The registry does not report numerical findings for these measures either. The safety fields offer some event counts, but lack details about attribution, timing, and overlap; they cannot fill the gap in primary efficacy results.

The planning description does not substitute for observed results. Sample-size illustrations based on an observed effect are planning tools under specified assumptions, not evidence that a treatment effect was present and not observed power. The original sample-size justification is not reported in the registry record. The most defensible interpretation is therefore limited: the record identifies the comparison, design, endpoint, and some safety counts, but does not contain the numerical outcome evidence needed to assess the primary question.

13. Why This Trial Matters Statistically

This trial raises a statistical question that is important whenever a complex intervention is added to an established procedure: what comparison does the design estimate, and how clearly is that comparison measured? The registry identifies randomization and a parallel-group comparison, which are relevant features for a causal comparison. At the same time, the record gives limited detail about allocation, other care, endpoint assessment, and analysis, all of which shape how confidently such a comparison can be interpreted.

The primary endpoint illustrates why outcome definitions matter. It is described both as a number of heart-wall segments with a perfusion defect and as a percentage of myocardial perfusion. Those descriptions may be connected through a defined calculation, but that calculation is not reported. A reader needs a clear scale and measurement procedure to understand what a mean represents and what size of difference would be meaningful.

The assessment at baseline and six months also makes the choice of estimand important. A follow-up comparison and a change-from-baseline comparison are not identical questions. When more than one time point or outcome is considered, a prespecified strategy is useful for distinguishing the primary inference from secondary exploration. The registry does not report such a strategy, and it does not provide an analysis result for the primary endpoint.

Finally, the record shows why trial design details and trial findings must be kept separate. Randomization, enrollment, and an outcome definition describe how a study was organized; they do not reveal the effect estimate or its precision. Without those numerical results, statistical interpretation must remain focused on what was planned and what information is missing rather than implying an outcome conclusion.

14. 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 available record leaves important aspects of the population and intervention unspecified. It identifies coronary artery disease and describes patients with low ejection fraction following CABG, but does not give detailed eligibility criteria or baseline participant characteristics. It describes the cell implantation route but does not report cell dose, preparation, timing details beyond the brief summary, or procedural standardization. The control arm is described as not receiving implantation, but other care in either group is not detailed.

The endpoint definition has an unresolved measurement description: the outcome is named as myocardial defect perfusion, described through a number of heart-wall segments, and assigned a percentage unit. The MRI reading method, scale, threshold, and calculation are not reported. The registry also does not provide the primary outcome values at baseline or six months, a between-group estimate, or measures of uncertainty. Thus, neither the size nor precision of the primary comparison can be assessed.

Important design and analysis details are absent. The method of randomization and allocation concealment, the roles affected by the absence of masking, the statistical model, baseline adjustment, missing-data method, analysis population, and multiplicity approach are not reported in the registry record. Participant flow and outcome-specific analysis counts are also unavailable. The record lists nine outcome measures, yet contains no analyses reported and does not give results for the named secondary measures.

Safety information is limited to grouped counts and selected serious-event terms. Event timing, attribution, overlap, collection methods, and details about the reported deaths are not given. These limitations restrict interpretation of both efficacy and safety; they do not establish that unreported procedures or analyses did not occur.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Transepicardial With Transseptal Autologous CD 133+ Bone Marrow Cell Implantation in Patient Following CABG Surgery — NCT02870933.
• Registry record last updated 2020-04-02; status last verified 2020-03.
• Results first posted 2020-04-02.
• 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.

18. Record Summary

NCT02870933 is recorded as a completed phase 4 randomized, parallel-group trial with no masking and enrollment of 30. It compared transepicardial with transseptal autologous CD 133+ bone marrow cell implantation during CABG with a control arm that did not receive implantation. The listed primary outcome is myocardial defect perfusion, assessed at baseline and six months by MRI and summarized as a mean and standard deviation.

The registry record does not report numerical primary or secondary outcome results, analysis estimates, confidence intervals, or p-values. It lists serious adverse-event counts of 2 among 13 at risk in the Subject group and 1 among 13 at risk in the Control group, as well as deaths of 2 and 1, respectively. Details about event attribution and timing are not reported. The record therefore describes the trial's design and outcome definitions but does not provide the results needed to assess the primary comparison.