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 Role of On-site CT-derived FFR in the Management of Suspect CAD Patients (NCT03901326), a randomized na study. The primary outcome is Number of Participants With ICA Without Obstructive CAD or Intervention.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03901326 |
| Phase | NA |
| Condition | Coronary Artery Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1216 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Chinese PLA General Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Patients with stable chest pain and suspected coronary artery disease were the focus of the trial. The registry describes a prospective study conducted in 6 Chinese hospitals and reports enrollment of 1216 participants. The primary endpoint description concerns patients who underwent planned invasive coronary angiography (ICA), but the full endpoint population and the number of participants meeting that condition are not reported in the registry record.
Intervention
The CTA/CT-FFR care pathway made CT-derived fractional flow reserve assessment available. The intervention is listed as a diagnostic test, and the registry names on-site CT-FFR assessment. The available arm description indicates that a CT-FFR result of 0.8 or lower in one or more major coronary arteries led to referral for ICA. The rest of the arm description is incomplete in the registry record.
Comparator
The comparison was routine clinically indicated diagnostic care. The registry describes clinicians deciding the next diagnostic step, with options including exercise ECG, stress cardiac echo, cardiac MR, and SPECT. It also states that examination results were considered alongside risk factors and clinical manifestations. The record does not give a complete account of subsequent clinical decisions.
Primary question
The primary endpoint counted participants with planned ICA who had no significant obstructive coronary artery disease or had no intervention during ICA within 90 days. Significant obstruction was defined as stenosis of at least 70% by core-lab quantitative analysis or invasive FFR of 0.8 or lower. The registry record does not report the endpoint counts or a comparison between the care groups, so the result for this question cannot be described from the record.
3. Trial Design
TARGET was a randomized, open-label, prospective, parallel-group trial. The registry reports enrollment of 1216 participants and describes assignment to routine clinically indicated diagnostic care or CTA/CT-FFR care using computer-generated random numbers in a 1:1 ratio. The record lists the trial status as completed. It gives a start date of 2019-05-10 and a primary completion date of 2022-10-30.
The study addressed care pathways for patients with stable chest pain and suspected coronary artery disease. In the CTA/CT-FFR group, on-site CT-derived fractional flow reserve assessment was available. The routine-care group could undergo diagnostic testing selected by attending physicians; the registry names exercise ECG, stress cardiac echo, cardiac MR, and SPECT as examples. Because the trial was open label, the record does not describe masking of participants or clinicians.
The registry identifies Chinese PLA General Hospital as the sponsor and states that the trial was to be performed in 6 Chinese hospitals. The listed phase is NA. The intervention is classified as a diagnostic test rather than a drug or device treatment. These design features frame the question as a comparison of diagnostic-management pathways, not simply a test of one treatment against another.
The record lists five outcome measures and five analyses, but does not report the full statistical analysis plan, the allocation concealment procedure, or the analysis populations. It also does not report whether there were interim analyses or how the enrollment target was justified. Those details cannot be inferred from the randomized design or from the planned 1:1 assignment.
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
| Stage | CTA/CT-FFR Care Group | Routine Clinically-indicated Diagnostic Care Group |
|---|---|---|
| STARTED | 608 | 608 |
| COMPLETED | 608 | 608 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: In the general population, patients with severe coronary stenosis maybe considered to be sent to catheter room, while the main endpoint is the negative findings during angiography. Therefore, for instance, the total population in the CT-FFR group is 608 (row1), of which 421 patients (row2, 3) enter the catheter room for coronary angiography. Therefore, the proportion of the three rows is different.
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 | CTA/CT-FFR Care Group | Routine Clinically-indicated Diagnostic Care Group | Total |
|---|---|---|---|---|
| Participants analysed | 608 | 608 | 1216 | |
| Age, Continuous | years | 60.0 (SD 8.3) | 59.2 (SD 11.5) | 59.6 (SD 10.0) |
| Sex: Female, Male: Female | Participants | 210 | 221 | 431 |
| Sex: Female, Male: Male | Participants | 398 | 387 | 785 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Body mass index | kg/m² | 25.1 (23.3 to 27.8) | 25.3 (23.0 to 27.3) | 25.2 (23.3 to 27.6) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With ICA Without Obstructive CAD or Intervention, measured over 90 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counted participants with planned invasive coronary angiography who had no significant obstructive coronary artery disease or had no intervention during ICA within 90 days. The registry defines significant obstruction as stenosis of at least 70% by core-lab quantitative analysis or invasive FFR of 0.8 or lower. Interventions named in the definition include stent implantation, balloon dilation, and bypass grafting.
This endpoint is intended to describe angiograms that did not identify the specified obstruction or result in the specified interventions. In the context of a diagnostic pathway comparison, such a count can be used to assess how often ICA occurred without the endpoint’s stated findings or procedures. Its interpretation depends on the registry’s exact wording: the record joins the absence of significant obstruction and the absence of intervention with “or,” so it is important not to silently replace that definition with a different composite or a narrower outcome.
The timeframe is 90 days. The registry’s population description is incomplete, and the endpoint counts by group are not reported in the registry record. Consequently, the endpoint’s observed frequency and the difference between care pathways cannot be stated from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant comparison between two diagnostic-care pathways, but it does not report the primary endpoint results. In particular, it gives no group-specific count of participants meeting the endpoint and no estimate of the between-group contrast. Therefore, the posted information does not establish whether one pathway was associated with more or fewer participants undergoing ICA without the specified findings or interventions.
The endpoint is a participant count within a 90-day period. For a fair comparison, interpretation would normally consider both the number meeting the endpoint and the number of participants in each analysis group who could contribute to that endpoint. The record’s general enrollment count is not a substitute for the group-specific endpoint denominators. The endpoint description refers to patients with planned ICA, but the number of such patients and the way this subset was defined are not reported in the registry record.
Randomization can support a comparison of assigned care pathways when the analysis follows an appropriate prespecified approach and outcome data are sufficiently complete. However, randomization by itself does not supply an effect estimate or show how missing observations, protocol deviations, or post-randomization decisions were handled. Those details are not reported in the registry record. The open-label design also means that participants and clinicians were not masked, as indicated by the trial’s masking field; the record does not describe any measures to reduce the effects of that design on decisions or outcome assessment.
The record lists secondary outcomes concerning major adverse cardiovascular events, medical expenditure, patient reporting outcomes, and cumulative radiation exposure. It does not provide their results in the information recorded. Nor does it describe the statistical methods used for those outcomes. These omissions prevent a statistical reading of the secondary findings, including their magnitude, precision, and relation to the primary endpoint.
General statistical context: an effect estimate describes the size and direction of a comparison, while a confidence interval describes the range of values compatible with the data under the model used. Neither is available for the primary endpoint in the registry record. Without counts, denominators, or an estimate with its uncertainty, the primary question cannot be answered quantitatively. This is a limitation of the posted results, not evidence that the groups were the same or that the endpoint did not occur.
9. Statistical Methods Explained
The trial is described as randomized and parallel group, with assignment intended to be in a 1:1 ratio. In general, random allocation aims to make groups comparable at the start of a study with respect to measured and unmeasured characteristics. It does not guarantee exact balance in any particular trial, and it does not replace reporting the analysis methods and results. The registry record does not describe allocation concealment or give baseline results in the information recorded.
What kind of outcome is the primary endpoint?
The endpoint is a count of participants meeting a binary condition: each participant either meets the stated endpoint definition during the 90-day timeframe or does not. For a binary outcome, a group comparison commonly reports the number of events alongside the relevant denominator, followed by an effect measure and an uncertainty interval. General examples of effect measures include a difference in event proportions or a ratio of event proportions. Those measures cannot be reconstructed without the group-specific endpoint counts and denominators, and they are not reported in the registry record.
The endpoint definition combines angiographic findings and procedures. It refers to the absence of significant obstructive disease using either a stenosis criterion or an invasive FFR criterion, and it also refers to whether an intervention was performed. For interpretation, the exact logical relationship between these parts matters. The registry uses “or” in its definition; readers should not assume a different Boolean rule, a different adjudication rule, or a narrower meaning than the wording states.
What would an estimate and confidence interval tell readers?
General statistical explanation: an estimate gives a numerical summary of the observed comparison, while a confidence interval conveys uncertainty around that estimate under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but an interval does not by itself establish clinical importance. A p-value, if reported, would address compatibility of the data with a specified null model; it would not measure the probability that the null hypothesis is true. The registry record does not report a primary endpoint estimate, confidence interval, or p-value.
Because the outcome is binary, its uncertainty depends in part on the number of participants with observed outcome status in each group. A total enrollment figure alone is insufficient: it does not reveal how many participants entered the endpoint population, how many had the event, or how many had missing outcome information. The registry’s endpoint population description is incomplete, and group-specific endpoint denominators and counts are not reported.
Why do analysis populations matter?
General statistical explanation: an intention-to-treat analysis usually compares participants according to randomized assignment, regardless of later care, while a per-protocol analysis applies specified adherence criteria. These approaches answer different questions and can be affected differently by events after randomization. The registry record does not identify the primary analysis population or say whether additional populations were analyzed. It also does not report how crossover, withdrawal, or other protocol deviations were treated.
Missing outcome data can weaken the interpretation of a randomized comparison if the absence of measurements is related to participant characteristics or outcomes. General approaches may include describing missingness, examining reasons for missing data, and conducting analyses under explicit assumptions. The registry record does not report missing-data counts, reasons, or methods, so no claim about completeness or handling is warranted.
What can be said about the planning illustrations?
The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation; they specify that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not trial outcomes and not observed power. The numerical planning results are not reported in the registry record. The record also does not report the trial’s own sample-size justification, so the illustrations should not be treated as evidence of the original design rationale.
General statistical explanation: planning for a smaller effect than an observed estimate generally requires more information to achieve a chosen level of power, but the numerical requirement depends on the model, outcome, event frequency, and assumptions. No new sample-size calculations can be made from the information in the registry record. For time-to-event outcomes, planning calculations may use event totals; for other outcomes they may use participants per arm, as the assumptions describe. Those distinctions concern planning, not the number of observed participants or events in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and five analyses. It identifies four secondary outcome categories: major adverse cardiovascular events, medical expenditure, patient reporting outcomes, and cumulative radiation exposure. The record does not report how many statistical comparisons were made within those categories, which outcomes were assigned to each analysis, or whether any outcomes had multiple time points or subgroups.
Multiplicity arises when several statistical tests or comparisons are conducted. In general, considering many results can increase the chance of at least one apparently notable finding, so a statistical analysis plan may specify a hierarchy, adjustment, or other approach. No multiplicity strategy is reported in the registry record. It is therefore not possible to determine whether the analyses were adjusted, prioritized, or treated as exploratory.
The record does not report the number of participants with missing primary or secondary outcome data, reasons for missingness, or methods used to address it. It also does not identify the primary analysis population, such as whether participants were analyzed according to randomized group or according to care received. These omissions matter because different handling of missing data and analysis populations can change both the estimate and its uncertainty. No conclusion about completeness, bias from missingness, or robustness across analysis populations is supported by the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| CTA/CT-FFR Care Group | 14 | 587 | 2.4% |
| Routine Clinically-indicated Diagnostic Care Group | 25 | 589 | 4.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| CTA/CT-FFR Care Group | 2 of 587 |
| Routine Clinically-indicated Diagnostic Care Group | 1 of 589 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| CTA/CT-FFR Care Group | 39 of 587 |
| Routine Clinically-indicated Diagnostic Care Group | 44 of 589 |
Most frequent serious adverse event terms
| Event term | Organ system | CTA/CT-FFR Care Group | Routine Clinically-indicated Diagnostic Care Group |
|---|---|---|---|
| Revascularization after 90 days | Cardiac disorders | 7 of 587 | 16 of 589 |
| Nonfatal myocardiol infraction | Cardiac disorders | 7 of 587 | 9 of 589 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CTA/CT-FFR Care Group | Routine Clinically-indicated Diagnostic Care Group |
|---|---|---|---|
| Hospitalization for unstable angina | Cardiac disorders | 39 of 587 | 44 of 589 |
Serious events with the highest arm-level rate: revascularization after 90 days (2.7%), nonfatal myocardiol infraction (1.5%).
The adverse-event entries report 14 serious adverse events among 587 participants at risk in the CTA/CT-FFR care group and 25 among 589 participants at risk in the routine clinically indicated diagnostic care group. The record also reports 39 other adverse events among 587 participants at risk in the CTA/CT-FFR group and 44 among 589 at risk in the routine-care group. It lists 2 deaths in the CTA/CT-FFR group and 1 in the routine-care group.
These are descriptive counts. The registry record does not report an analysis of the differences, uncertainty intervals, attribution to the diagnostic pathways, or details needed to interpret follow-up completeness. The counts alone cannot establish that a pathway caused an event or that the groups differ in safety. The record lists “Revascularization after 90 days” at 2.7% and “Nonfatal myocardiol infraction” at 1.5% among the top serious-event terms. These entries should be read as registry listings, not as comparative estimates or causal findings.
12. What the Result Does, and Does Not, Mean
The trial’s design addresses whether making CT-derived FFR available as part of a diagnostic-care pathway changes management compared with routine clinically indicated diagnostic care. Its primary endpoint focuses on participants who underwent planned ICA and had no significant obstructive disease or no intervention during ICA within 90 days. That endpoint can describe an aspect of the use and yield of invasive angiography, but the registry record does not report the endpoint counts or comparison.
Accordingly, the posted information does not show the size, direction, or precision of a primary-outcome difference. It cannot establish that either care pathway reduced unnecessary procedures, improved clinical prognosis, or changed medical expenditure. Those aims appear in the registry’s brief summary, but aims are not findings. The registry also names secondary outcomes, yet their results are not reported in the record.
General statistical context: a non-significant result, if one were reported, would not by itself prove equivalence or absence of an effect; a sufficiently precise interval would be needed to assess which differences remain compatible with the data. Conversely, a statistically notable result would not by itself show that an effect is important in practice. Neither kind of interpretation is possible without the relevant estimates and uncertainty.
The available design information supports describing the study as a randomized comparison of diagnostic pathways, not as proof of benefit or harm. The conclusion must remain limited to what the registry record reports: trial design, enrollment, endpoint definition, and selected adverse-event counts are listed, while primary and secondary outcome results are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically interesting because the intervention is a diagnostic-management pathway rather than a single treatment. The pathway could influence whether further testing or invasive coronary angiography is pursued, while the comparator allows clinicians to choose among routine diagnostic options. The primary endpoint therefore reflects a downstream clinical process and its findings, rather than a direct measurement of the CT-FFR test alone.
Randomization offers a framework for comparing the assigned pathways, but interpreting that comparison requires transparent endpoint counts, denominators, analysis choices, and uncertainty estimates. These details are especially important when the endpoint concerns only participants with planned ICA. If the endpoint analysis is restricted to a group defined after randomization, that restriction may affect how the comparison should be interpreted; the registry record does not explain the analysis population or the handling of this issue.
The trial also lists outcomes spanning clinical events, expenditure, patient-reported outcomes, and radiation exposure. These domains address different questions and may require different statistical methods. Without reported results and a multiplicity plan, their relative evidential weight cannot be assessed. The registry record’s lack of primary endpoint results means the central quantitative comparison cannot be evaluated, despite the availability of several design details.
The study illustrates why registry interpretation distinguishes a trial’s aims and methods from its findings. Enrollment and randomization describe how a study was organized; they do not reveal the observed effect. Clear reporting of estimates, uncertainty, missing data, and analysis populations is necessary to understand what the comparison can support.
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 main limitation for interpreting the trial is that primary endpoint results are not reported in the registry record. No group-specific endpoint counts, denominators, effect estimate, or measure of uncertainty are available in the record. The endpoint population description is also incomplete, so the number of participants with planned ICA and the analysis set cannot be determined.
The registry’s primary endpoint wording combines the absence of significant obstructive coronary artery disease and the absence of intervention during ICA. Because the definition uses “or,” its exact classification rule should be preserved when interpreting any results. The record does not provide further detail on endpoint adjudication, handling of ambiguous findings, or whether core-lab assessment was blinded to assigned group.
The trial is listed as open label. The registry does not describe whether decisions about further testing and ICA were subject to safeguards against knowledge of the assigned pathway, nor does it report any assessment of deviations from the intended care pathways. Randomization procedures are described at a high level, but allocation concealment is not reported in the registry record.
Missing-data methods, analysis populations, multiplicity handling, and the statistical analysis plan are not reported. The registry also does not provide the numerical sample-size planning illustrations or the trial’s own sample-size justification. These gaps limit assessment of precision, potential bias, and the robustness of any results; they do not establish that the study was poorly conducted.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Role of On-site CT-derived FFR in the Management of Suspect CAD Patients — NCT03901326.
- Registry record last updated 2024-05-31; status last verified 2023-12.
- Results first posted 2024-05-31.
- 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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18. Record Summary
The registry identifies NCT03901326 as the TARGET trial, titled “Role of On-site CT-derived FFR in the Management of Suspect CAD Patients.” It describes a randomized, open-label, prospective, parallel-group study sponsored by Chinese PLA General Hospital, with 1216 participants enrolled. The trial is listed as completed, with a start date of 2019-05-10 and a primary completion date of 2022-10-30.
The comparison was CTA/CT-FFR care versus routine clinically indicated diagnostic care for patients with stable chest pain. The primary endpoint concerned ICA without significant obstructive coronary artery disease or intervention within 90 days. The registry record does not report the primary endpoint results, secondary outcome results, full statistical analysis plan, missing-data methods, or analysis populations. It lists selected serious and other adverse-event counts, but does not report comparative safety analyses.