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

Cardiac Disease Clinical Trial

— MI  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05700032
• Other study ID #: 0134-20-FB
• Status: Withdrawn
• Phase: N/A
• Start date: August 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: October 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI	Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI	10 minutes
Secondary	stroke volume	The volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction	10 minutes