Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

Study Overview
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Brief Summary
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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.

Official Title
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Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

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

Intervention / Treatment
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* Drug: Sonazoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be scheduled for cardiac catheterization procedure. Be at least 18 years of age. Be medically stable. If a female of child-bearing potential, must have a negative pregnancy test. Be conscious and able to comply with study procedures. Have signed Informed Consent to participate in the study. 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 Females who are pregnant or nursing. Patients not scheduled for cardiac catheterization procedure. Patients who have received an investigational drug in the 30 days before, or will receive one within 72 h after, study drug administration. Patients currently on chemotherapy or with other primary cancers requiring treatment. Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalised urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of SONAZOID). Patients with congenital heart defects. Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli. Patients with respiratory distress syndrome or a contraindication to pharmacological vasodilator stress agents. Patients with thrombosis within the hepatic, portal, or mesenteric veins.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonazoid for pressure measurements<br>48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% sodium chloride solution infused at a rate of at least 2 ml/min. | Drug: Sonazoid<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 Sonazoid 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?
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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 | 
| Accuracy of ventricular relaxation rate and relaxation time constant | ANOVA/Post-hoc comparisons | up to 1 day | 

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