Phase 2
N=80
Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
Cardiac Catheterization · Blood Pressure · Heart Ventricles · Echocardiography · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03245255 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Agreement Between SHAPE and Pressure Catheter Measurements — -0.8; -0.8 Correlation coefficient value
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sonazoid (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement Between SHAPE and Pressure Catheter Measurements |
-0.8; -0.8 | — |
| PRIMARY Error Between SHAPE and Pressure Catheter Measurements |
5.4; 6.6; 5.8; 1.2 | — |
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-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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03245255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.