Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

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.

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Key information

Conditions

Cardiac Catheterization Blood Pressure Cardiovascular Diseases Echocardiography Heart Diseases Heart Failure Heart Ventricles

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Thomas Jefferson University and Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Definity

Drug

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.

Primary outcomes

Agreement between SHAPE and pressure catheter measurements

Time frame: up to 1 day

Correlation
Error between SHAPE and pressure catheter measurements

Time frame: up to 1 day

ANOVA/Post-hoc comparisons

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

American Heart Association
Lantheus Medical Imaging

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Aug 9, 2017
Registry last updated: Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed