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 A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD. (NCT01347710), a na phase 3 study. The primary outcome is Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01347710 |
| Phase | Phase 3 |
| Condition | Coronary Artery Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 795 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Lantheus Medical Imaging |
| Results posted | Yes |
2. Clinical Question
Population
Patients with suspected or known coronary artery disease referred for coronary catheterization. The primary analysis population was defined as safety-evaluable patients with evaluable rest and stress PET and SPECT imaging data, as well as evaluable invasive coronary angiography.
Intervention
Flurpiridaz F 18 injection for myocardial perfusion imaging with PET. The study description specifies a single dose and one-day rest and stress PET imaging.
Comparator
A single dose of 99mTc sestamibi or tetrofosmin for myocardial perfusion imaging with SPECT. This was not a randomized control arm; both imaging procedures were included in the diagnostic comparison.
Primary question
How does the sensitivity of flurpiridaz F 18 PET imaging compare with SPECT imaging for detecting coronary artery disease, using invasive coronary angiography and a majority-rule interpretation as the truth standard?
The clinical question is about diagnostic classification, not about whether one imaging procedure changes health outcomes. Sensitivity concerns how often an imaging test identifies disease among cases considered to have disease under the chosen reference standard. The registry describes the primary outcome as a count of true-positive cases and specifies a 95% confidence interval, but it does not include the observed sensitivity estimates or their intervals.
The record also lists comparisons of specificity, subgroup sensitivity and specificity, localization of disease, multivessel disease, and image quality. These are additional diagnostic questions, and their presence does not substitute for the missing primary estimate. The record does not report the result values for these analyses either. The findings therefore cannot be judged from the registry record as to the size or precision of any difference between PET and SPECT.
3. Trial Design
This was a completed Phase 3, multicenter, open-label study sponsored by Lantheus Medical Imaging. The registry lists enrollment of 795 and gives the study dates as 2011-06 for the start and 2013-07 for primary completion. Its stated objective was to assess the diagnostic efficacy of flurpiridaz F 18 PET myocardial perfusion imaging compared with SPECT myocardial perfusion imaging in detecting significant coronary artery disease.
The study is classified as single-group, with allocation listed as not applicable and masking listed as none. The record describes patients undergoing rest and stress flurpiridaz F 18 PET imaging and SPECT imaging. Thus, this is not a randomized comparison of separate treatment groups. The imaging procedures are compared as diagnostic tests, in a population with evaluable results for both tests and invasive coronary angiography. The comparison is not a like-for-like control-arm comparison, and a treatment effect interpretation would be inappropriate.
The reference standard was invasive coronary angiography, with the primary description referring to a majority-rule determination. The brief study summary also mentions significant coronary artery disease as defined by invasive coronary angiography or a documented history of myocardial infarction. The primary outcome description specifically identifies invasive coronary angiography as its truth standard and describes a population with evaluable angiography. The registry record does not explain how the broader definition in the summary relates to the primary analysis definition.
The primary analysis population was restricted to safety-evaluable patients who had evaluable rest and stress PET and SPECT procedures and evaluable invasive coronary angiography. The record does not provide the number of patients meeting each of those conditions or explain the handling of patients excluded from the primary analysis. The study's detailed recruitment flow and analysis-population counts are not reported in the registry record.
Open-label status means masking is not listed. The registry record does not describe whether image readers or those determining the reference-standard diagnosis were masked to other findings. It also does not report further details about the conduct of image interpretation. Such information would help readers assess the possibility that knowledge of one test result influenced interpretation of another, but should not be assumed either way.
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 | Flurpiridaz F 18 |
|---|---|
| STARTED | 795 |
| COMPLETED | 764 |
| NOT COMPLETED | 31 |
Reasons for not completing this period:
| Reason | Flurpiridaz F 18 |
|---|---|
| Withdrawal by Subject | 2 |
| Adverse Event | 4 |
| Angio or SPECT not completed | 18 |
| issue with vitals prior to dosing | 1 |
| Lost to Follow-up | 1 |
| Physician Decision | 2 |
| Other | 3 |
Analysis population for the primary outcome, as defined in the registry: All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography
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: Safety population, received at least one dose of flurpiridaz F 18
| Characteristic | Unit | Flurpiridaz F 18 |
|---|---|---|
| Participants analysed | 795 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 458 |
| Age, Categorical: >=65 years | Participants | 337 |
| Sex: Female, Male: Female | Participants | 249 |
| Sex: Female, Male: Male | Participants | 546 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 43 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 708 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 44 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 2 |
| Race (NIH/OMB): Asian | Participants | 8 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 4 |
| Race (NIH/OMB): Black or African American | Participants | 105 |
| Race (NIH/OMB): White | Participants | 652 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 24 |
6. Primary Endpoint
The registry lists the primary outcome as Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity, measured over 60 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Proportion of true positive cases |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is diagnostic sensitivity for flurpiridaz F 18 PET myocardial perfusion imaging compared with SPECT myocardial perfusion imaging. The registry describes the measure as the proportion of true-positive cases and specifies a 95% confidence interval. The timeframe is 60 days. The outcome description refers to one-day rest and stress imaging and detection of coronary artery disease using invasive coronary angiography as the truth standard, with majority-rule assessment.
Sensitivity is the proportion of cases classified as having disease by the reference standard that are also identified as positive by the imaging test. It addresses detection among diseased cases; it does not describe how often a negative test correctly classifies people without disease. Specificity addresses that latter question, and is listed among the secondary outcomes.
Sensitivity is useful for assessing a diagnostic test because a missed case is a different classification error from a false positive. However, sensitivity alone does not convey the full diagnostic performance of a test. It should be interpreted alongside specificity, the reference standard, the analysis population, and the uncertainty around the estimate. The registry record does not report the primary sensitivity values, the number of true-positive cases, or the confidence interval limits. Therefore, the endpoint is defined, but its observed result and precision cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the intended comparison: sensitivity of flurpiridaz F 18 PET myocardial perfusion imaging versus SPECT myocardial perfusion imaging for detection of coronary artery disease. It identifies the reference standard, describes the eligible analysis population, and specifies a 95% confidence interval. Those details clarify what the primary outcome was meant to measure. They do not provide the outcome estimate itself.
No primary sensitivity estimate, corresponding SPECT sensitivity estimate, difference between the tests, or confidence interval limits are reported in the registry record. There is consequently no numerical basis in this record for describing the direction, size, or precision of the primary comparison. It would be inappropriate to say that one test had higher sensitivity or that the tests performed similarly. A missing estimate is not evidence of equivalence, and it is not evidence that a comparison failed to find a difference.
The same caution applies to the listed secondary diagnostic outcomes. The record describes subgroup comparisons for pharmacologic stress, females, and BMI at least 30, as well as evaluations of specificity, disease localization, multivessel disease, and image quality. It does not give their result values. The existence of an analysis in a registry listing does not show what it found, whether it was prespecified in detail, or how it was interpreted by the investigators.
The enrollment entry is 795, but this should not be mistaken for the primary analysis denominator. The primary population required evaluable results from both imaging procedures and invasive coronary angiography, in addition to being safety-evaluable. The record does not report how many enrolled patients met those requirements, nor the number of reference-standard-positive cases that would form the sensitivity denominator. Without those counts and estimates, the amount of information underlying the primary comparison cannot be evaluated.
The single-group classification and absence of randomization matter for interpretation. This is a diagnostic-test comparison, not a randomized evaluation of clinical outcomes or treatment assignment. The record's description of both imaging procedures permits a paired diagnostic comparison among patients with evaluable data, but the statistical method used to account for that pairing is not reported in the registry record. A paired analysis can use the fact that results from two tests in the same people are related; treating them as independent would not represent that structure. The record does not state how this issue was handled.
The registry does report that the study is completed, but completion status does not itself supply the missing results. The number of analyses listed also signals that the primary endpoint sits among multiple diagnostic and subgroup questions. Without an analysis plan or multiplicity details, readers cannot determine whether secondary findings were adjusted for multiple testing or treated as exploratory. The main conclusion supported by this record is therefore limited: it documents a planned diagnostic comparison and its endpoint definition, while the outcome estimates needed to judge performance are not reported in the registry record.
9. Statistical Methods Explained
The primary endpoint is a diagnostic measure rather than a time-to-event or treatment-response measure. Sensitivity describes the proportion of cases that are positive on the imaging test among those classified as having coronary artery disease by the reference standard. Specificity, which appears among the secondary outcomes, describes the proportion classified as negative among those considered not to have disease. These measures answer complementary questions. Neither by itself describes the probability that a particular patient has disease given a test result; that interpretation also depends on the prevalence of disease in the population being assessed.
What is the reference standard doing?
For a diagnostic-accuracy analysis, test classifications need a comparator that defines disease status for the purpose of calculating true-positive and false-positive classifications. The primary description identifies invasive coronary angiography as the truth standard and says classification used a majority rule. The registry does not explain the majority-rule process, who made the judgments, or how disagreements were resolved. These details affect reproducibility and can influence which cases count as having disease.
The brief study summary also describes significant coronary artery disease as defined by invasive coronary angiography or a documented history of myocardial infarction. The primary outcome description, however, specifically refers to invasive coronary angiography. The registry does not clarify whether the documented-history definition was applied to the primary analysis, another outcome, or a different study objective. The reader should keep the primary endpoint description distinct from the broader wording in the summary rather than assume the definitions are interchangeable.
Why do paired test results matter?
The eligible primary population had evaluable PET and SPECT procedures, as well as evaluable angiography. This setup means the diagnostic comparison concerns results from both tests in a common patient population, rather than outcomes from separate randomized arms. Results from two tests measured in the same people are generally related. A statistical comparison should account for this pairing when estimating uncertainty or testing a difference, because the way one test classifies a person can be associated with the way the other test classifies that person.
The registry record does not report the statistical procedure used for comparing the two sensitivities. It also does not describe whether the test readers were masked, how image quality was handled in the primary analysis, or whether the paired structure was taken into account. These are not details that can be reconstructed from the endpoint label alone. The absence of that information limits independent appraisal of the analysis, but does not establish that a particular method was or was not used.
What does a confidence interval communicate?
A confidence interval expresses statistical uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision for that estimate, while a wider interval indicates less precision. It does not by itself describe whether the estimate is clinically important, and it does not correct for bias in test interpretation, an imperfect reference standard, or missing data. The registry specifies a 95% confidence interval for the primary outcome but does not report its limits or the method used to calculate it.
Because no confidence interval values are present, the precision of the primary sensitivity estimate cannot be judged. Nor can readers determine from the registry whether an interval for a difference between tests was calculated. An interval for each test's sensitivity and an interval for the paired difference are not the same statistical quantity. The record's endpoint wording identifies the comparative question, but does not disclose all the estimates needed to assess it.
How should the multiple analyses be viewed?
The record lists 12 outcome measures and 22 analyses. These include subgroup sensitivity and specificity comparisons, localization and multivessel-disease evaluations, and summaries restricted to images rated excellent or good. Each additional analysis creates another opportunity to observe a result that may appear notable by chance, particularly when the analysis is not prespecified or is one of many being considered. Multiplicity methods can control or describe that risk, but the appropriate approach depends on the purpose and structure of the analyses.
The registry record does not report whether multiplicity adjustment was planned or used, how the 22 analyses map to the 12 outcome measures, or which analyses were designated confirmatory. It also does not describe a hierarchy of endpoints. Readers should therefore avoid treating an unreported subgroup or secondary result as confirmatory, and should not assume that all listed analyses had equal status.
The record includes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such planning illustrations are hypothetical design calculations, not observed power and not evidence that the study was designed around those assumptions. The record does not report the trial's own sample-size justification or statistical plan. Further, because the study is single-group and its diagnostic comparison is not a randomized two-arm comparison, equal allocation between arms in an illustration should not be read as a description of how this study was conducted.
Over-dispersion is a general statistical concern when observed variability exceeds what a chosen model assumes. If a model fails to account for that extra variability, standard errors can be too small and intervals or tests can overstate precision. The registry record does not identify a model for the primary endpoint or report an over-dispersion assessment, so no conclusion about its relevance to this analysis can be made. This is a general methodological point, not a claim about the study's analysis.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 12 outcome measures and 22 analyses. Alongside the primary sensitivity comparison, it includes secondary evaluations of specificity, subgroup performance, localization of coronary artery disease, multivessel disease, and image quality. The record does not state which analyses were formally confirmatory, whether a hierarchy was used, or whether any correction for multiple testing was applied. Multiplicity handling is not reported in the registry record.
This matters because interpretation of a collection of results differs from interpretation of one prespecified primary comparison. When many outcomes or subgroups are tested, some apparently notable findings can arise by chance. Adjustment procedures, prespecified ordering, or clear designation of exploratory analyses can help readers understand how much weight to give individual results. None of those details can be inferred solely from the list of outcomes.
The registry record also does not report the primary endpoint result values or secondary result values, so it is not possible to assess whether any multiplicity method affected their interpretation. It does not provide the analysis plan, the statistical tests used, or the decision rules for handling multiple comparisons.
The primary analysis population required evaluable PET and SPECT data and evaluable invasive coronary angiography, with safety evaluability also specified. The numbers excluded at each stage, reasons for missing or unevaluable data, and methods for handling missing results are not reported in the registry record. The record does not say whether patients with incomplete testing were excluded, imputed, or addressed through another method. These omissions prevent assessment of how selection into the evaluable population might affect the diagnostic estimates.
The sample-size illustrations are planning calculations, not observed power. The registry does not report the trial's own sample-size justification or whether an interim analysis was planned or conducted. Those features of the statistical plan are not reported in 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 |
|---|---|---|---|
| Flurpiridaz F 18 | 20 | 795 | 2.5% |
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 |
|---|---|
| Flurpiridaz F 18 | 555 of 795 |
Most frequent serious adverse event terms
| Event term | Organ system | Flurpiridaz F 18 |
|---|---|---|
| Angina Pectoris | Cardiac disorders | 6 of 795 |
| Ventricular Tachycardia | Cardiac disorders | 2 of 795 |
| Atrial Flutter | Cardiac disorders | 1 of 795 |
| Cardiac Failure Congestive | Cardiac disorders | 1 of 795 |
| Cardiogenic Shock | Cardiac disorders | 1 of 795 |
| Inguinal Hernia | Gastrointestinal disorders | 1 of 795 |
| Catheter Site Haemorrhage | General disorders | 1 of 795 |
| Non-Cardiac Chest Pain | General disorders | 1 of 795 |
| Pneumonia | Infections and infestations | 1 of 795 |
| Hypoglycaemia | Metabolism and nutrition disorders | 1 of 795 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Flurpiridaz F 18 |
|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 200 of 795 |
| Headache | Nervous system disorders | 129 of 795 |
| Angina Pectoris | Cardiac disorders | 119 of 795 |
| Electrocardiogram ST Segment Depressions | Investigations | 75 of 795 |
| Percutaneous coronary intervention | Surgical and medical procedures | 72 of 795 |
| Fatigue | General disorders | 70 of 795 |
| Flushing | Vascular disorders | 60 of 795 |
| Non-Cardiac Chest Pain | General disorders | 58 of 795 |
| Nausea | Gastrointestinal disorders | 44 of 795 |
| Dizziness | Nervous system disorders | 43 of 795 |
Serious events with the highest arm-level rate: angina pectoris (0.8%), ventricular tachycardia (0.3%), atrial flutter (0.1%), cardiac failure congestive (0.1%), cardiogenic shock (0.1%).
For the Flurpiridaz F 18 group, the registry reports 20 participants affected by serious adverse events among 795 at risk, and 555 affected by other adverse events among 795 at risk. These are separate registry categories; the counts should not be added, since a participant may be represented in more than one category. The record does not report deaths for this group; a missing death entry should not be interpreted as a reported count of zero.
The listed serious adverse event terms and percentages are Angina Pectoris, 0.8%; Ventricular Tachycardia, 0.3%; Atrial Flutter, 0.1%; Cardiac Failure Congestive, 0.1%; Cardiogenic Shock, 0.1%; and Inguinal Hernia, 0.1%. The record does not establish from these entries whether terms overlap within participants or whether these are all serious event terms. The percentages should be read as the registry lists them, not as a complete account of comparative risk.
These safety counts are descriptive. The study is listed as single-group, with no randomized control arm, so the entries do not provide a randomized comparison of adverse-event rates. The registry record does not provide a detailed event-by-event narrative, duration, severity grading beyond the serious category, or attribution assessment. The entries describe what was recorded for the study group, but cannot by themselves establish causation or comparative safety.
12. What the Result Does, and Does Not, Mean
The record defines a Phase 3 diagnostic study comparing flurpiridaz F 18 PET myocardial perfusion imaging with SPECT imaging in patients with suspected or known coronary artery disease. It describes sensitivity as the primary outcome and names invasive coronary angiography as the primary truth standard. It also describes the population required for the primary analysis: safety-evaluable patients with evaluable rest and stress results from both imaging procedures and evaluable angiography.
Those design details explain the question the study was intended to address. They do not establish the answer. The registry record does not report the primary sensitivity estimate for either test, the difference between them, or the 95% confidence interval. As a result, the available information does not show whether PET sensitivity was higher, lower, or similar to SPECT sensitivity, nor how precise an estimate may have been.
The record also does not report the numerical findings for its secondary outcomes. The presence of planned subgroup and other diagnostic analyses should not be treated as evidence that those analyses favored one test. Without their estimates and uncertainty, neither subgroup patterns nor the consistency of results across outcomes can be assessed.
This was not a randomized treatment trial. Its single-group, open-label design and diagnostic purpose mean that conclusions should be framed around test classification against the stated reference standard, not treatment benefit or clinical outcomes. The registry does not report whether readers were masked or how the analysis accounted for paired test results; those details could matter to interpretation.
The adverse-event entries describe counts recorded for the Flurpiridaz F 18 group, but no randomized comparator is available for a direct safety contrast. They should not be used to infer relative risk. Overall, the record supports a description of the study design, endpoint, analysis population, and reported safety counts. It does not provide the efficacy results needed to characterize diagnostic performance or make a numerical comparison between PET and SPECT.
13. Why This Trial Matters Statistically
This study is statistically notable as a diagnostic-test comparison in which the primary question concerns sensitivity against a reference standard. Diagnostic accuracy studies require careful definition of both the disease classification and the patient population being evaluated. Here, the record identifies invasive coronary angiography and a majority-rule assessment for the primary comparison, and requires evaluable data from both imaging procedures. Those features matter because sensitivity depends on which cases are classified as having disease and which patients contribute to the estimate.
The comparison also raises a central design issue: both imaging procedures are described for the eligible population, so the statistical comparison is not the same as comparing independent randomized groups. Properly representing paired classifications can affect the uncertainty around a difference. The registry record does not identify the specific comparison method, which limits the reader's ability to verify how the design and data structure were reflected in the analysis.
Another important point is the distinction between having a defined endpoint and having interpretable results. The record provides the endpoint concept and a confidence-interval specification, but not the values needed to judge performance or precision. In the absence of those results, the study's diagnostic question remains clear while the answer cannot be evaluated from the registry record.
The registry also lists many secondary outcomes and analyses. This makes transparency about prespecification and multiplicity relevant: subgroup and secondary findings can be difficult to interpret without knowing their status in the analysis plan and how multiple comparisons were addressed. Those methods are not reported in the registry record.
Finally, the record illustrates why enrollment alone is not enough to understand a diagnostic analysis. The endpoint population is narrower than everyone enrolled because evaluable imaging and reference-standard data are required. The numbers eligible for the primary analysis and the handling of missing or unevaluable results are not reported. These details are necessary to assess how representative the analyzed cases were and how much information supports the estimates.
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 most important limitation of the registry record is that it does not report the primary diagnostic results. There are no sensitivity estimates, comparison estimates, or confidence-interval limits for the primary endpoint. The listed secondary outcomes likewise lack numerical results. This prevents assessment of the magnitude, direction, and precision of the planned diagnostic comparisons.
The primary analysis population is defined by evaluable results from both imaging procedures and invasive coronary angiography, but the number meeting those criteria is not reported. Nor are the reasons for unavailable or unevaluable data, exclusions, or any procedures for handling missing observations. Enrollment of 795 therefore does not reveal how much data contributed to the primary endpoint.
The study is open-label and masking is listed as none. The registry record does not report whether PET or SPECT image readers, angiography assessors, or other evaluators were masked to relevant findings. It does not provide enough detail about majority-rule assessment to evaluate how disease classifications were produced or how disagreement was resolved.
The brief summary refers to disease defined by angiography or documented history of myocardial infarction, while the primary outcome description specifically names invasive coronary angiography as the truth standard. The record does not clarify the relationship between these definitions for the primary analysis. This leaves uncertainty about how the summary wording applies to the endpoint population.
The registry record does not report the statistical plan, the comparison procedure for paired test results, multiplicity handling, or the trial's own sample-size justification. It also does not describe whether interim analyses occurred. These omissions limit assessment of prespecification and analysis choices. The adverse-event data are descriptive for a single study group and do not provide a randomized safety comparison.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD. — NCT01347710.
- Registry record last updated 2020-11-24; status last verified 2014-08.
- Results first posted 2016-04-05.
- 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
NCT01347710 is a completed Phase 3, multicenter, open-label, single-group study sponsored by Lantheus Medical Imaging. It enrolled 795 and compared flurpiridaz F 18 PET myocardial perfusion imaging with 99mTc sestamibi or tetrofosmin SPECT imaging for diagnostic assessment of coronary artery disease. The primary outcome was sensitivity against invasive coronary angiography using a majority-rule assessment, with a specified 95% confidence interval and a 60-day timeframe.
The registry describes an analysis population requiring safety-evaluable status and evaluable PET, SPECT, and angiography data. It also lists secondary diagnostic outcomes and subgroup analyses. Primary and secondary efficacy estimates, the detailed statistical plan, multiplicity procedures, and missing-data handling are not reported in the registry record. For the Flurpiridaz F 18 group, the record lists 20 participants affected by serious adverse events and 555 affected by other adverse events, with 795 at risk in each category. The entries are descriptive and do not form a randomized comparison.