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NCT03354273 · ClinicalTrials.gov registry record · Phase 3
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
A Phase 3 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 730
- Enrollment target
NCT03354273: Completed Phase 3 study, sponsored by GE Healthcare.
NCT03354273 is a Phase 3 study that has completed, run by GE Healthcare. The registered enrollment target is 730 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03354273, a Phase 3 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 730 participants
- Enrollment target
Study Summary
This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
Primary Outcome
Sensitivity was defined as true positives (TP)/(TP+false negatives \[FN\]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives \[FP\]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was pr
Interventions
- DRUG PET MPI
- DRUG SPECT MPI
- DRUG Pharmacological stress agents
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 730 participants |
| Start Date | 2018-06-05 |
| Est. Completion | 2022-05-05 |
| Phase | Phase 3 |
What the finished NCT03354273 record still lists
NCT03354273 is an interventional study that assigns participants to a tested intervention. The registered 730 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which PET MPI is the first listed.
NCT03354273 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03354273 about?
NCT03354273 is a clinical study titled "An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)". This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
What is the current status of trial NCT03354273?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 730 participants. The study started on 2018-06-05. Estimated completion is 2022-05-05.
What interventions are being tested in trial NCT03354273?
The interventions under investigation include: PET MPI (DRUG), SPECT MPI (DRUG), Pharmacological stress agents (DRUG).
Who is sponsoring clinical trial NCT03354273?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03354273's enrollment target sits among peer trials
730 489th of 2000 higher than 1,512 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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