Trials / Completed
CompletedNCT03243942
Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Thomas Jefferson University · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The fundamental hypothesis of this project is that real-time intracardiac pressures can be monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired intracardiac 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Definity | Whenever a patient undergoes cardiac catheterization, which routinely includes intracardiac pressure monitoring using a pressure catheter, as part of their standard clinical care and agrees to participate in the study, we will acquire research data. With Definity infusion, SHAPE algorithm will be initiated to determine optimum acoustic pressure. Then, at the optimum acoustic pressure SHAPE specific data will be acquired from the cardiac chambers and aorta synchronously with the pressures recorded by the catheter (as a part of the patient's standard of care). After acquiring the ultrasound imaging data, the remainder of the heart catheterization will be completed by the attending cardiologist according to the patients' standard of care. |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2019-06-26
- Completion
- 2019-06-26
- First posted
- 2017-08-09
- Last updated
- 2019-07-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03243942. Inclusion in this directory is not an endorsement.