Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Completed · Phase 2

Conditions studied: Cardiac Catheterization, Blood Pressure, Heart Ventricles, Echocardiography, Heart Failure

In brief

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.

Key facts

Study ID

NCT03243942

Run by

Thomas Jefferson University

People needed

56

Starts

2017-06-01

Expected to finish

2019-06-26

Last updated by the study team

2019-07-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Thomas Jefferson University and Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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