Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Study Overview
=================
Brief 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.

Official Title
-----------------
Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Conditions
-----------------
Cardiac Catheterization, Blood Pressure, Heart Ventricles, Echocardiography, Heart Failure

Intervention / Treatment
-----------------
* Drug: Definity


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Definity for pressure measurements<br>2 vials of activated Definity mixed with 50 ml saline. As per manufacturer's recommendation the infusion rate may vary between 4-10 ml/min (to provide diagnostic intracardiac contrast visibility). | Drug: Definity<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between SHAPE and pressure catheter measurements | Correlation | up to 1 day | 
| Error between SHAPE and pressure catheter measurements | ANOVA/Post-hoc comparisons | up to 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pressure measurements, blood pressure, contrast echocardiography, ventricular pressures, catheterization