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Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Primary Purpose

Cardiac Catheterization, Blood Pressure, Heart Ventricles

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Definity

About this trial

This is an interventional diagnostic trial for Cardiac Catheterization focused on measuring pressure measurements, blood pressure, contrast echocardiography, ventricular pressures, catheterization

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be scheduled for a cardiac catheterization procedure
Adult patients over the age of 21
Acceptable baseline echocardiographic images in the supine position
If a female of child-bearing potential, must have a negative pregnancy test
Provide written informed consent

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
Patients with anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts where Definity could traverse as a bolus
Patients with known hypersensitivity to Definity
Females who are pregnant or nursing

Sites / Locations

Thomas Jefferson University and Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Definity for pressure measurements

Arm Description

2 vials of activated Definity mixed with 50 ml saline. As per manufacturer's recommendation the infusion rate may vary between 4-10 ml/min (to provide diagnostic intracardiac contrast visibility).

Outcomes

Primary Outcome Measures

Agreement between SHAPE and pressure catheter measurements

Correlation

Error between SHAPE and pressure catheter measurements

ANOVA/Post-hoc comparisons

Secondary Outcome Measures

Full Information

NCT ID

NCT03243942

First Posted

August 3, 2017

Last Updated

July 9, 2019

Sponsor

Thomas Jefferson University

Collaborators

American Heart Association, Lantheus Medical Imaging

1. Study Identification

Unique Protocol Identification Number

NCT03243942

Brief Title

Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Official Title

Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

June 26, 2019 (Actual)

Study Completion Date

June 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thomas Jefferson University

Collaborators

American Heart Association, Lantheus Medical Imaging

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The fundamental hypothesis of this project is that real-time intracardiac pressures can be monitored and quantified noninvasively in humans using a novel contrast-enhanced ultrasound technique called subharmonic-aided pressure estimation (SHAPE).This study will use contrast echocardiography to assess the accuracy of SHAPE compared to simultaneously acquired intracardiac 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Catheterization, Blood Pressure, Heart Ventricles, Echocardiography, Heart Failure

Keywords

pressure measurements, blood pressure, contrast echocardiography, ventricular pressures, catheterization

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Definity for pressure measurements

Arm Type

Experimental

Arm Description

2 vials of activated Definity mixed with 50 ml saline. As per manufacturer's recommendation the infusion rate may vary between 4-10 ml/min (to provide diagnostic intracardiac contrast visibility).

Intervention Type

Drug

Intervention Name(s)

Definity

Intervention Description

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 Definity 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 Measure Information:

Title

Agreement between SHAPE and pressure catheter measurements

Description

Correlation

Time Frame

up to 1 day

Title

Error between SHAPE and pressure catheter measurements

Description

ANOVA/Post-hoc comparisons

Time Frame

up to 1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be scheduled for a cardiac catheterization procedure Adult patients over the age of 21 Acceptable baseline echocardiographic images in the supine position If a female of child-bearing potential, must have a negative pregnancy test Provide written informed consent 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 Patients with anatomic right-to-left, bi-directional, or transient right-to-left cardiac shunts where Definity could traverse as a bolus Patients with known hypersensitivity to Definity Females who are pregnant or nursing

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaydev Dave

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University and Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing Time Frame

2019-05-30 (anticipated) or starting 6 months after publication

IPD Sharing Access Criteria

Accessible research platform

Citations:

PubMed Identifier

21989870

Citation

Dave JK, Halldorsdottir VG, Eisenbrey JR, Liu JB, McDonald ME, Dickie K, Leung C, Forsberg F. Noninvasive estimation of dynamic pressures in vitro and in vivo using the subharmonic response from microbubbles. IEEE Trans Ultrason Ferroelectr Freq Control. 2011 Oct;58(10):2056-66. doi: 10.1109/TUFFC.2011.2056.

Results Reference

background

PubMed Identifier

22724314

Citation

Dave JK, Halldorsdottir VG, Eisenbrey JR, Forsberg F. Processing of subharmonic signals from ultrasound contrast agents to determine ambient pressures. Ultrason Imaging. 2012 Apr;34(2):81-92. doi: 10.1177/016173461203400202.

Results Reference

background

PubMed Identifier

23347593

Citation

Dave JK, Halldorsdottir VG, Eisenbrey JR, Merton DA, Liu JB, Machado P, Zhao H, Park S, Dianis S, Chalek CL, Thomenius KE, Brown DB, Forsberg F. On the implementation of an automated acoustic output optimization algorithm for subharmonic aided pressure estimation. Ultrasonics. 2013 Apr;53(4):880-8. doi: 10.1016/j.ultras.2012.12.010. Epub 2013 Jan 2.

Results Reference

background

PubMed Identifier

22561300

Citation

Dave JK, Halldorsdottir VG, Eisenbrey JR, Raichlen JS, Liu JB, McDonald ME, Dickie K, Wang S, Leung C, Forsberg F. Subharmonic microbubble emissions for noninvasively tracking right ventricular pressures. Am J Physiol Heart Circ Physiol. 2012 Jul;303(1):H126-32. doi: 10.1152/ajpheart.00560.2011. Epub 2012 May 4.

Results Reference

background

PubMed Identifier

22239898

Citation

Dave JK, Halldorsdottir VG, Eisenbrey JR, Raichlen JS, Liu JB, McDonald ME, Dickie K, Wang S, Leung C, Forsberg F. Noninvasive LV pressure estimation using subharmonic emissions from microbubbles. JACC Cardiovasc Imaging. 2012 Jan;5(1):87-92. doi: 10.1016/j.jcmg.2011.08.017.

Results Reference

background

PubMed Identifier

23525208

Citation

Eisenbrey JR, Dave JK, Halldorsdottir VG, Merton DA, Miller C, Gonzalez JM, Machado P, Park S, Dianis S, Chalek CL, Kim CE, Baliff JP, Thomenius KE, Brown DB, Navarro V, Forsberg F. Chronic liver disease: noninvasive subharmonic aided pressure estimation of hepatic venous pressure gradient. Radiology. 2013 Aug;268(2):581-8. doi: 10.1148/radiol.13121769. Epub 2013 Mar 22.

Results Reference

background

PubMed Identifier

16060506

Citation

Forsberg F, Liu JB, Shi WT, Furuse J, Shimizu M, Goldberg BB. In vivo pressure estimation using subharmonic contrast microbubble signals: proof of concept. IEEE Trans Ultrason Ferroelectr Freq Control. 2005 Apr;52(4):581-3. doi: 10.1109/tuffc.2005.1428040.

Results Reference

background

PubMed Identifier

21842580

Citation

Halldorsdottir VG, Dave JK, Leodore LM, Eisenbrey JR, Park S, Hall AL, Thomenius K, Forsberg F. Subharmonic contrast microbubble signals for noninvasive pressure estimation under static and dynamic flow conditions. Ultrason Imaging. 2011 Jul;33(3):153-64. doi: 10.1177/016173461103300301.

Results Reference

background

PubMed Identifier

10320317

Citation

Shi WT, Forsberg F, Raichlen JS, Needleman L, Goldberg BB. Pressure dependence of subharmonic signals from contrast microbubbles. Ultrasound Med Biol. 1999 Feb;25(2):275-83. doi: 10.1016/s0301-5629(98)00163-x.

Results Reference

background

PubMed Identifier

24856899

Citation

Halldorsdottir VG, Dave JK, Eisenbrey JR, Machado P, Zhao H, Liu JB, Merton DA, Forsberg F. Subharmonic aided pressure estimation for monitoring interstitial fluid pressure in tumours--in vitro and in vivo proof of concept. Ultrasonics. 2014 Sep;54(7):1938-44. doi: 10.1016/j.ultras.2014.04.022. Epub 2014 May 6.

Results Reference

background

PubMed Identifier

35079778

Citation

Esposito C, Machado P, Cohen IS, Mehrotra P, Savage M, Fischman D, Davis M, Ruggiero N, Walinsky P, McDonald ME, Dickie K, Forsberg F, Dave JK. Comparing Central Aortic Pressures Obtained Using a SphygmoCor Device to Pressures Obtained Using a Pressure Catheter. Am J Hypertens. 2022 May 10;35(5):397-406. doi: 10.1093/ajh/hpac010.

Results Reference

derived

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Noninvasive, Subharmonic Intra-Cardiac Pressure Measurement

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