Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

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.

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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 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.

Treatment and study plan

Sonazoid

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 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.

Primary outcomes

Agreement Between SHAPE and Pressure Catheter Measurements

Time frame: up to 1 day

The Pearson correlation coefficient was computed between the simultaneously acquired subharmonic signal and pressure catheter data (i.e., waveforms) for each participant. The Pearson correlation coefficient was used for comparing waveforms given the underlying data and pressure values used for comparisons followed a normal distribution. Values reported will be the mean Pearson correlation coefficient values between the subharmonic waveforms and pressure catheter waveforms obtained.
Error Between SHAPE and Pressure Catheter Measurements

Time frame: up to 1 day

Based on the distribution of the differences in cardiac pressure values obtained using the SHAPE technique and the clinical pressure catheter, either a two-tailed paired t test (normal distribution) or Wilcoxon signed rank test (nonnormal distribution) was used to compare the SHAPE technique to the reference standard. Bonferroni corrections were used for multiple comparisons

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

GE Healthcare
National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2023
First posted: Aug 10, 2017
Registry last updated: May 29, 2024

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.

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Completed