Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Phase 2

Completed

• Conditions: Cardiac Catheterization; Blood Pressure; Heart Ventricles; Echocardiography; Heart Failure
• Interventions: Drug: Definity

• Registration Number: NCT03243942
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-09
• Primary Completion: 2019-06-26
• Study Completion: 2019-06-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definity for pressure measurements	Definity	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).

Primary Outcome Measures

Name	Time	Method
Agreement between SHAPE and pressure catheter measurements	up to 1 day	Correlation
Error between SHAPE and pressure catheter measurements	up to 1 day	ANOVA/Post-hoc comparisons

Trial Locations

Locations (1)

Thomas Jefferson University and Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States