Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

NCT03243942•Thomas Jefferson University

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Thomas Jefferson University and Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

June 1, 2017

Primary Completion Date

June 26, 2019

Completion Date

June 26, 2019

Last Updated

July 10, 2019

Enrollment

ACTUAL participants

Conditions

Cardiac CatheterizationBlood PressureHeart VentriclesEchocardiographyHeart Failure

Interventions

Definity

DRUG

Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial

NCT07482930

Vagus Nerve StimulationsSpirometry+3 more

View study

RECRUITINGNA

Community-based Implementation of Adapted STAC

NCT06689930

Blood PressureHypertension+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Inclusion Criteria

Exclusion Criteria

Transcutaneous Auricular Vagus Nerve Stimulation and Spirometry: Sham-Controlled Randomized Trial

Community-based Implementation of Adapted STAC

Inspiratory Muscle Strength Training for Lowering Blood Pressure and Improving Endothelial Function in Postmenopausal Women: Comparison With "Standard of Care" Aerobic Exercise

Addressing Hypertension Care in Africa Program

Forebrain Electroneutral Transporters in Salt-sensitive Hypertension: an MRI Study

How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes