NCT05700032

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

January 17, 2023

Last Update Submit

August 30, 2024

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

  • Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI

    Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI

    10 minutes

Secondary Outcomes (1)

  • stroke volume

    10 minutes

Study Arms (2)

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

high MI impulsesDIAGNOSTIC_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.

high MI
low MI impulsesDIAGNOSTIC_TEST

patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.

low MI

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 19 years or older

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Swethika Harini Sundaravel, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

January 26, 2023

Study Start

February 15, 2021

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

September 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share