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

Sponsor

University of Nebraska (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05700032

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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 LVOT VTI.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Diagnostic Test: high MI impulses Diagnostic Test: low MI impulses	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

LVOT VTI [10 minutes]

Secondary Outcome Measures

stroke volume [10 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

age 19 years or older

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Nebraska

ClinicalTrials.gov Identifier:

NCT05700032

Other Study ID Numbers:

134-20-FB

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of Jan 26, 2023