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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05700032

Acronym

Enrollment

Registered

2023-01-26

Start date

2021-02-15

Completion date

2021-02-15

Last updated

2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

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).

Interventions

DIAGNOSTIC_TESThigh 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.

DIAGNOSTIC_TESTlow MI impulses

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026