Cardiac DiseaseMINCT05700032
Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles
A study testing high MI impulses and low MI impulses in people with Cardiac Disease, run by University of Nebraska.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- high MI impulses and low MI impulses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2021to 15 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 19 years or older
Who cannot join
- 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.
About this study
Official title: The Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume in Patients Receiving Intravenous Microbubbles
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.
Read the 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).
- Conditions
- Cardiac Disease
- Being tested
- high MI impulses, low MI impulses
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
low MI impulsesDiagnostic test
patients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol.
| Study group | Role | What they receive |
|---|---|---|
| high MI | Experimental | patients receiving high MI impulses Receives: Diagnostic Test: high MI impulses |
| low MI | Active comparator | patients receiving low MI impulses Receives: Diagnostic Test: low MI impulses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
Measured: 10 minutes
Secondary outcomes (1)
stroke volume
The volume of blood pumped out of the left ventricle of the heart during each systolic cardiac contraction
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start15 Feb 2021
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Why it stopped: Due to clinical service demand study was withdrawn and not activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swethika Harini Sundaravel, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700032
- Sponsor's protocol ID
- 0134-20-FB
- Acronym
- MI
- Status last verified
- Aug 2024
- First submitted
- 17 Jan 2023
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume in Patients Receiving Intravenous Microbubbles
- ClinicalTrials.gov ID
- NCT05700032
- Acronym / sponsor ID
- MI / 0134-20-FB
- Conditions
- Cardiac Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to clinical service demand study was withdrawn and not activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high MI | Experimental | Diagnostic Test: high MI impulsespatients receiving high MI impulses |
| low MI | Active comparator | Diagnostic Test: low MI impulsespatients receiving low MI impulses |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 19 years or older
Key exclusion criteria (8 listed)
- severe aortic valve stenosis
- pregnant or lactating women
- atrial fibrillation
- very poor image quality despite contrast use.
- unstable cardiac condition such as cardiogenic shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high MI impulsespatients 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 test | high MI |
| low MI impulsespatients will receive low MI imaging only. LVOT VTI will be measured at different times per protocol. | Diagnostic test | low MI |
Primary outcome
Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
Time frame: 10 minutes
Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI
1 secondary outcome
stroke volume
Time frame: 10 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swethika Harini Sundaravel, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing high MI impulses and low MI impulses in people with Cardiac Disease, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricle Outflow Tract (LVOT) First Ventilatory Threshold VTI (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.