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Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03245255
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : September 23, 2020
National Heart, Lung, and Blood Institute (NHLBI)
GE Healthcare
Information provided by (Responsible Party):
Thomas Jefferson University

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-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.

Condition or disease Intervention/treatment Phase
Cardiac Catheterization Blood Pressure Heart Ventricles Echocardiography Heart Failure Drug: Sonazoid Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
Actual Study Start Date : December 4, 2017
Actual Primary Completion Date : September 18, 2020
Actual Study Completion Date : September 18, 2020

Arm Intervention/treatment
Experimental: Sonazoid for pressure measurements
48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% sodium chloride solution infused at a rate of at least 2 ml/min.
Drug: Sonazoid
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 Outcome Measures :
  1. Agreement between SHAPE and pressure catheter measurements [ Time Frame: up to 1 day ]

  2. Error between SHAPE and pressure catheter measurements [ Time Frame: up to 1 day ]
    ANOVA/Post-hoc comparisons

  3. Accuracy of ventricular relaxation rate and relaxation time constant [ Time Frame: up to 1 day ]
    ANOVA/Post-hoc comparisons

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03245255

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United States, Pennsylvania
Thomas Jefferson University and Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
National Heart, Lung, and Blood Institute (NHLBI)
GE Healthcare
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Principal Investigator: Jaydev K Dave Thomas Jefferson University

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Responsible Party: Thomas Jefferson University Identifier: NCT03245255    
Other Study ID Numbers: R21HL130899 ( U.S. NIH Grant/Contract )
R21HL130899 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This project will generate pressure values in the aorta, and left and right ventricles using the proposed research method (i.e., SHAPE) and using the standard of care (i.e., catheter based pressure values). Additionally peripheral and central pressures will be generated. All of the pressure values will be made available. Further, all ultrasound data obtained for SHAPE measurements will be made available after anonymizing the data-set to remove any patient information
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 2018-08-01 (anticipated) or starting 6 months after publication
Access Criteria: Accessible research platform

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Jefferson University:
pressure measurements
blood pressure
contrast echocardiography
ventricular pressures
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases