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NCT03245255 · ClinicalTrials.gov registry record · Phase 2
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
A Phase 2 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT03245255: Completed Phase 2 study, sponsored by Thomas Jefferson University.
NCT03245255 is a Phase 2 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03245255, a Phase 2 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will use contrast echocardiography to assess the accuracy of a new non-invasive imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously acquired intra-cardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.
Primary Outcome
The Pearson correlation coefficient was computed between the simultaneously acquired subharmonic signal and pressure catheter data (i.e., waveforms) for each participant. The Pearson correlation coefficient was used for comparing waveforms given the underlying data and pressure values used for comparisons followed a normal distribution. Values reported will be the mean Pearson correlation coefficient values between the subharmonic waveforms and pressure catheter waveforms obtained.
Interventions
- DRUG Sonazoid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2023-06-07 |
| Phase | Phase 2 |
What the finished NCT03245255 record still lists
NCT03245255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Sonazoid is the first listed.
NCT03245255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03245255 about?
NCT03245255 is a clinical study titled "Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound". This study will use contrast echocardiography to assess the accuracy of a new non-invasive imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously acquired intra-cardiac pressures measured invasively during cardiac catheterization. This study is designed to verify...
What is the current status of trial NCT03245255?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2017-12-04. Estimated completion is 2023-06-07.
What interventions are being tested in trial NCT03245255?
The interventions under investigation include: Sonazoid (DRUG).
Who is sponsoring clinical trial NCT03245255?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03245255's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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