DiagnosisPOCUS_ACQNCT05631977
Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care
An observational study of Diagnosis, run by Aisap LTD at 3 sites in 2 countries.
Trial summary
The present study is a preparatory step towards a multi-reader multi case (MRMC) randomized fully crossed study. As POCUS images are frequently not stored and not methodically acquired using a standardized image acquisition protocol this study will collect cardiac POCUS images in a prespecified manner. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnosis
- What is being tested?
- Point of care ultrasound cardiac examination
- How many people
- 300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Jan 2023to 30 Jun 2023
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals under the care of the cardiology institutes of the participating sites, both inpatients and outpatient clinics and services.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 21 or more
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unstable clinical condition according to PI clinical judgment
- Presence of prosthetic cardiac valve at any position and any type
- Pregnancy or lactation
- Contact isolation due to infections disease
- Presence of left ventricular assist device (LVAD)
Show all 14Show fewer
- Know existence of congenital heart disease
- Prosthetic cardiac valve, any
- BMI 40 or greater
- Clinical conditions that do not permit a POCUS study according to the judgment of the investigators or treating physicians
- History of lung resection
- Known poor cardiac US image quality based on prior echo exams
- Mechanical ventilation, or other situations where the required ultrasound views cannot be adequately obtained
- Clinical instability or critical subject condition or any condition the study PI judges that the POCUS exam could adversely affect the participant
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Inova Health
Fairfax, Virginia, 22031
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
The present study is a preparatory step towards a multi-reader multi case (MRMC) randomized fully crossed study. As POCUS images are frequently not stored and not methodically acquired using a standardized image acquisition protocol this study will collect cardiac POCUS images in a prespecified manner.
- Conditions
- Diagnosis
- Being tested
- Point of care ultrasound cardiac examination
- Keywords
- Point of care ultrasound, Echocardiography
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasound cardiac examinationOther
The study intervention consists of a POCUS cardiac examination by site approved personal using an FDA cleared US scanner. Usual care of study participants will not be impacted.
| Study group | Role | What they receive |
|---|---|---|
| POCUS acquisition | Prospective noninterventional single arm study collection of cardiac POCUS examination according to prespecified acquisition protocol.
Alongside POCUS images the study will also collect demographic and clinical information from the study participants and some information from the healthcare personal performing the POCUS exam (experience in US image acquisition, physician specialty or sonographer).
Patient management will not be impacted, and usual care will follow the regular practices at the study site. Receives: Other: Point of care ultrasound cardiac examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
POCUS QUALITY
Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard)
Measured: 1 month
Secondary outcomes (1)
Subgroup analysis
Analysis of primary endpoint (POCUS exam quality) by the prespecified subgroups of age (above or below 65), gender, BMI group (below or above 25) and US device manufacturer.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start23 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aisap LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631977
- Sponsor's protocol ID
- POC1
- Acronym
- POCUS_ACQ
- Status last verified
- Dec 2023
- First submitted
- 17 Nov 2022
- Last updated
- 3 Jan 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Acquisition of Cardiac Ultrasound Images at the Point of Care
- ClinicalTrials.gov ID
- NCT05631977
- Acronym / sponsor ID
- POCUS_ACQ / POC1
- Conditions
- Diagnosis
- Keywords
- Point of care ultrasound, Echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Aisap LTDIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 30 Nov 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 present study is a preparatory step towards a multi-reader multi case (MRMC) randomized fully crossed study. As POCUS images are frequently not stored and not methodically acquired using a standardized image acquisition protocol this study will collect cardiac POCUS images in a prespecified manner.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POCUS acquisition | – | Other: Point of care ultrasound cardiac examinationProspective noninterventional single arm study collection of cardiac POCUS examination according to prespecified acquisition protocol. Alongside POCUS images the study will also collect demographic and clinical information from the study participants and some information from the healthcare personal performing the POCUS exam (experience in US image acquisition, physician specialty or sonographer). Patient management will not be impacted, and usual care will follow the regular practices at the study site. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals under the care of the cardiology institutes of the participating sites, both inpatients and outpatient clinics and services.
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 21 or more
Key exclusion criteria (14 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unstable clinical condition according to PI clinical judgment
- Presence of prosthetic cardiac valve at any position and any type
- Pregnancy or lactation
- Contact isolation due to infections disease
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 |
|---|---|---|
| Point of care ultrasound cardiac examinationThe study intervention consists of a POCUS cardiac examination by site approved personal using an FDA cleared US scanner. Usual care of study participants will not be impacted. | Other | POCUS acquisition |
Primary outcome
POCUS QUALITY
Time frame: 1 month
Primary endpoint: Percent of POCUS exams that attain the pre-specified POCUS image quality threshold (quality standard)
1 secondary outcome
Subgroup analysis
Time frame: 1 month
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 3 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis, run by Aisap LTD at 3 sites in 2 countries.
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 4 inclusion and 14 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel. 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?
POCUS QUALITY (time frame: 1 month). 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 3 Jan 2024.