Impact of High Mechanical Index Ultrasound Impulses on Le... | NCT05700032

Studies
Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles

NCT05700032

Sponsor

University of Nebraska

Status

Withdrawn

Last Update Posted

Sep 4, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cardiac Disease

Interventions

high MI impulses
low MI impulses

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to clinical service demand study was withdrawn and not activated

Expanded Access Info

Start Date

Feb 15, 2021Actual

Primary Completion Date

Feb 15, 2021Actual

Completion Date

Feb 15, 2021Actual

First Submitted Date

Jan 17, 2023

First Submission Date that Met QC Criteria

Jan 17, 2023

First Posted Date

Jan 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2024

Last Update Posted Date

Sep 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high MI	Experimental	patients receiving high MI impulses	Diagnostic Test: high MI impulses
low MI	Active Comparator	patients receiving low MI impulses	Diagnostic Test: low MI impulses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high MI impulses	Diagnostic Test	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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Swethika Harini Sundaravel, MD	University of Nebraska	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided