Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:21 - Any
Updated:4/29/2018
Start Date:December 4, 2017
End Date:March 31, 2019
Contact:Jaydev K Dave
Email:jaydev.dave@jefferson.edu
Phone:2159554806

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
1
site
132 South 10th Street
Philadelphia, Pennsylvania 19107
Phone: 215-955-4806
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials