Status:
COMPLETED
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
GE Healthcare
Conditions:
Cardiac Catheterization
Blood Pressure
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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-ca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03245255
Start Date
December 4 2017
End Date
June 7 2023
Last Update
May 29 2024
Active Locations (1)
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1
Thomas Jefferson University and Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107