Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 9/13/2018 |
| Start Date: | June 1, 2017 |
| End Date: | June 30, 2019 |
| Contact: | Jaydev K Dave |
| Email: | jaydev.dave@jefferson.edu |
| Phone: | 2159554806 |
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.
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.
Inclusion Criteria:
- Be scheduled for a cardiac catheterization procedure
- Adult patients over the age of 21
- Acceptable baseline echocardiographic images in the supine position
- If a female of child-bearing potential, must have a negative pregnancy test
- Provide written informed consent
Exclusion Criteria:
- Clinically unstable patients, e.g., those who are clinically in decompensated heart
failure or having active chest pain or presenting for admission with an unstable
anginal syndrome
- Patients in whom introduction of a catheter into the left ventricle is contraindicated
or would potentially be dangerous, e.g., patients with active ventricular arrhythmias
or with significant aortic valve stenosis where crossing the aortic valve may be
difficult and not clinically necessary
- Patients with anatomic right-to-left, bi-directional, or transient right-to-left
cardiac shunts where Definity could traverse as a bolus
- Patients with known hypersensitivity to Definity
- Females who are pregnant or nursing
We found this trial at
1
site
132 South 10th Street
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Phone: 215-955-4806
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