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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.
 
ClinicalTrials.gov Identifier: NCT03245255
Recruitment Status : Completed
First Posted : August 10, 2017
Last Update Posted : September 23, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
GE Healthcare
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE August 4, 2017
First Posted Date  ICMJE August 10, 2017
Last Update Posted Date September 23, 2020
Actual Study Start Date  ICMJE December 4, 2017
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
  • Agreement between SHAPE and pressure catheter measurements [ Time Frame: up to 1 day ]
    Correlation
  • Error between SHAPE and pressure catheter measurements [ Time Frame: up to 1 day ]
    ANOVA/Post-hoc comparisons
  • Accuracy of ventricular relaxation rate and relaxation time constant [ Time Frame: up to 1 day ]
    ANOVA/Post-hoc comparisons
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
Official Title  ICMJE Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cardiac Catheterization
  • Blood Pressure
  • Heart Ventricles
  • Echocardiography
  • Heart Failure
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Sonazoid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 18, 2020
Actual Primary Completion Date September 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03245255
Other Study ID Numbers  ICMJE R21HL130899( U.S. NIH Grant/Contract )
R21HL130899 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • GE Healthcare
Investigators  ICMJE
Principal Investigator: Jaydev K Dave Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP