Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles (MI)

The Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume in Patients Receiving Intravenous Microbubbles

This study will investigate whether applying high mechanical index (MI) impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent (UEA) microbubble infusion will result in subclinical improvement in left ventricle systolic function.

Study Overview

• Status: Withdrawn
• Conditions: Cardiac Disease
• Intervention / Treatment: Diagnostic test: high MI impulses; Diagnostic test: low MI impulses

Detailed Description

The purpose of this study is to investigate whether applying high MI impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent(UEA) microbubble infusion will result in subclinical improvement in LV systolic function detected by left ventricular outflow tract velocity time integral (LVOT VTI).

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

age 19 years or older

Exclusion Criteria:

1. severe aortic valve stenosis
2. pregnant or lactating women
3. atrial fibrillation
4. very poor image quality despite contrast use.
5. unstable cardiac condition such as cardiogenic shock.
6. allergy to UEA
7. presence of right to left or bidirectional shunts.
8. Patients on mechanical circulatory support.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high MI; patients receiving high MI impulses	Diagnostic test: high MI impulses; patients will receive intermittent high MI impulses(>1.0) in addition to low MI imaging. LVOT VTI will be measured at different times per protocol.
Active Comparator: low MI; patients receiving low MI impulses	Diagnostic test: low MI impulses; patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI	Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke volume	The volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction	10 minutes

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Swethika Harini Sundaravel, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: 0134-20-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No