Stroke VolumeBES2TNCT05506059
Heart Ultrasound by Emergency Medicine Residents as an Estimate of Heart Function
A study testing Ultrasound in people with Stroke Volume and Cardiovascular Diseases, run by The Guthrie Clinic at 1 site in United States.
Trial summary
The purpose of this research is to better understand the use of heart ultrasounds to estimate heart function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke Volume, Cardiovascular Diseases
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2022to 11 Aug 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers, or patients who come to the emergency department who may have a heart echocardiogram scheduled as part of their routine clinical care
- Age 18 or over
- Willing and able to provide informed consent
Who cannot join
- Pediatrics (age <18 years old).
- No cardiac-altering intervention performed between examiners.
- Unable to obtain a parasternal long view with mitral valve anterior leaflet, interventricular septum and aortic root.
- Transthoracic echocardiogram (TTE) more than the next day after EPSS is performed (for secondary outcome).
- Female with known pregnancy.
- Prisoner
- Prior cardiac surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
The Robert Packer Hospital
Sayre, Pennsylvania, 18840
About this study
Official title: "BES2T" (Bedside E-point Septal Separation Test) for Emergency Medicine Residents
The purpose of this research is to better understand the use of heart ultrasounds to estimate heart function.
Read the detailed description
This research involves ultrasounds of the heart by two different emergency medicine doctors who are residents in training. Results from the two doctors will be compared to see how similar they are. This research will help us understand if heart ultrasounds can be used to see how well the heart pumps blood and if similar results are obtained from different doctors.
The doctors will use ultrasound of the heart to measure E-Point Septal Separation (EPSS). EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. EPSS is measured in millimeters (mm). EPSS can estimate left ventricular ejection fraction (LVEF) as a measure of how well the heart pumps blood.
- Conditions
- Stroke Volume, Cardiovascular Diseases
- Being tested
- Ultrasound
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Participants will have ultrasounds of the heart by two different emergency medicine doctors.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Other | Healthy volunteers over the age of 18 who consent to two ultrasounds. Receives: Diagnostic Test: Ultrasound |
| ED patient with planned heart echocardiogram | Experimental | Patients in emergency department (ED) who have a heart echocardiogram scheduled as part of their routine clinical care Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians
Two physicians will use the same ultrasound device to measure the E-Point Septal Separation (EPSS) on the same patients. EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. The mean change in EPSS measurements in millimeter will be calculated.
Measured: During procedure
Secondary outcomes (1)
Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.
Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram. LVEF (in %) will be estimated from ultrasound using the formula = 75.5 - (2.5 x E-Point Septal Separation in millimeters)
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start10 Sep 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke VolumeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dean Licurgo, DO, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506059
- Sponsor's protocol ID
- 2206-26
- Acronym
- BES2T
- Status last verified
- Feb 2024
- First submitted
- 16 Aug 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "BES2T" (Bedside E-point Septal Separation Test) for Emergency Medicine Residents
- ClinicalTrials.gov ID
- NCT05506059
- Acronym / sponsor ID
- BES2T / 2206-26
- Conditions
- Stroke Volume, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 18 Aug 2022 (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.
The purpose of this research is to better understand the use of heart ultrasounds to estimate heart function.
Detailed description
This research involves ultrasounds of the heart by two different emergency medicine doctors who are residents in training. Results from the two doctors will be compared to see how similar they are. This research will help us understand if heart ultrasounds can be used to see how well the heart pumps blood and if similar results are obtained from different doctors.
The doctors will use ultrasound of the heart to measure E-Point Septal Separation (EPSS). EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. EPSS is measured in millimeters (mm). EPSS can estimate left ventricular ejection fraction (LVEF) as a measure of how well the heart pumps blood.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | Other | Diagnostic Test: UltrasoundHealthy volunteers over the age of 18 who consent to two ultrasounds. |
| ED patient with planned heart echocardiogram | Experimental | Diagnostic Test: UltrasoundPatients in emergency department (ED) who have a heart echocardiogram scheduled as part of their routine clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteers, or patients who come to the emergency department who may have a heart echocardiogram scheduled as part of their routine clinical care
- Age 18 or over
- Willing and able to provide informed consent
Key exclusion criteria (7 listed)
- Pediatrics (age <18 years old).
- No cardiac-altering intervention performed between examiners.
- Unable to obtain a parasternal long view with mitral valve anterior leaflet, interventricular septum and aortic root.
- Transthoracic echocardiogram (TTE) more than the next day after EPSS is performed (for secondary outcome).
- Female with known pregnancy.
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 |
|---|---|---|
| UltrasoundParticipants will have ultrasounds of the heart by two different emergency medicine doctors. | Diagnostic test | ED patient with planned heart echocardiogram, Healthy Volunteer |
Primary outcome
Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians
Time frame: During procedure
Two physicians will use the same ultrasound device to measure the E-Point Septal Separation (EPSS) on the same patients. EPSS is the distance between two parts of the heart, the mitral valve and the ventricular septum. The mean change in EPSS measurements in millimeter will be calculated.
1 secondary outcome
Percent change in Left Ventricular Ejection Fraction (LVEF) estimated from ultrasound compared to a formal transthoracic echocardiogram.
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 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.
Dean Licurgo, DO principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Stroke Volume and Cardiovascular Diseases, run by The Guthrie Clinic at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change in millimeters between E-Point Septal Separation (EPSS) measurements of the heart by two physicians (time frame: During procedure). 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 13 Feb 2024.