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AzTrials

Heart DiseasesNCT05563701

Evaluation of the LVivo Image Quality Scoring (IQS)

An observational study of Heart Diseases and Arrhythmia, Cardiac, run by DiA Imaging Analysis Ltd at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study includes two parts: Part 1: 100 examinations of patient referred for echo evaluation, containing clips that were acquired from the 4CH apical view were collected retrospectively. Read more about this study

Who is it for?
Ages 18 years and older
How many people
164 participants
Where
1 siteIsrael
Study dates
5 Sep 2022to 13 Sep 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Part 1 Patients age ≥18 referred for echo evaluation Part 2 Patients age ≥18 with indication for POCUS examination

Who may be able to join

  • Part 1 Study:
  • Age ≥18
  • Referred to routine Echo examination
  • Part 2 Study:
  • Age ≥18
  • Indication for POCUS

Who cannot join

  • Part 1 Study:
  • 1. Subjects who fail to meet any inclusion criteria
  • Part 2 Study:
  • Subjects who fail to meet any inclusion criteria
  • Image quality 1-2 according to ACEP June 2018 [11]

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Soroka university medical center

    Beersheba

Other trials in Israel

About this study

The study includes two parts:

Part 1:

Read more
  • 100 examinations of patient referred for echo evaluation, containing clips that were acquired from the 4CH apical view were collected retrospectively. Each study includes 10 clips that represent typical user scanning errors
  • Offline evaluation of the system (by batch processing) shall be performed by comparing the system output to preliminary quality tagging by experienced sonographers

Part 2:

  • Live scans of apical 4CH clips of patients with indication for POCUS examination will be performed by POC physicians
  • LVivo IQS shall be used (on Lumify) during the scan for patients that meet inclusion criteria until 50 exams will be collected. 3 sec of each scan shall be saved, and Image quality score (IQS) shall be documented
  • Saved scans shall be reviewed by an expert physician to determine whether they are clinically interpretable
Read the detailed description

Part 1 Total of 424 examination were collected from two medical centers. Participants that were referred to routine echo examinations and signed an informed consent were enrolled to the study. The image acquisition was done using ultrasound devices available in the medical centers. In addition Lumify ultrasound device was supplied by the sponsor.

Each examination contained 10 clips, each representing a different scanning scenario where the image acquisition contained transitions between common user "acquisition error" to correctly acquired images.

The examinations in DICOM format and echo reports were collected after anonymization, the patient details were documented in a study log that was stored in the medical center.

The collected clips were tagged for image quality by experienced sonographers. The distribution of the collected data according to ultrasound devices, age, gender and LV function was analyzed.

The data was randomly split into training and clinical validation sets, such that the proportion of data according to data distribution was maintained and the data set for the clinical evaluation will contain 100 patient examinations.

The LVivo IQS algorithm will be applied to the clinical validation set automatically by batch processing. The image quality score provided by the LVivo IQS will be compared to the image quality tagging by the sonographers

Part 2 The trial is designed as a prospective multicenter study, enrolling 50 patients at two medical centers. In each medical center Lumify ultrasound devices on which the LVivo IQS demo software will be installed will be provided for image acquisition. The image acquisition will be done by POC medical doctors, at different stages of their internship, that received POCUS training during their medical studies and are using ultrasound devices in accordance with their routine workflow. The scans will be done in different POC units including ER, ICU and internal departments.

Keywords
Echocardiography (Echo), Image Quality Scoring (IQS), Ultrasound (US), Point of Care (POC), 4CH (Four (4) Chamber of the heart view), LV (Left Ventricle), ER (Emergency Room), ICU (Intensive Care Unit), EF (Ejection Fraction)
Medical subject headings
Heart Diseases, Arrhythmias, Cardiac, Angina Pectoris, Angina, Unstable, Lung Diseases, Heart Failure, Shock, Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Overall agreement of 75% between image quality classification by LVivo IQS and the data tagging by experienced sonographers

    Measured: Up to 24 weeks

  2. Part 2: 80% of the Exams with image quality 3-5 by visual estimation, received at least "Medium" image quality by LVivo IQS

    Measured: Up to 24 weeks

  3. Part 2: 90% of these cases (when at least "Medium" image quality is indicated by LVivo IQS) are clinically interpretable

    Measured: Up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2022
  2. Study start5 Sep 2022
  3. Primary completion13 Sep 2022
  4. Study completion13 Sep 2022

Resources

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
Other
Time perspective
Prospective
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05563701
Sponsor's protocol ID
CR2P0021
Status last verified
Sep 2022
First submitted
22 Sep 2022
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Johri AM, Galen B, Kirkpatrick JN, Lanspa M, Mulvagh S, Thamman R. ASE Statement on Point-of-Care Ultrasound during the 2019 Novel Coronavirus Pandemic. J Am Soc Echocardiogr. 2020 Jun;33(6):670-673. doi: 10.1016/j.echo.2020.04.017. Epub 2020 Apr 15.

    PubMed 32503704

  • Hashim A, Tahir MJ, Ullah I, Asghar MS, Siddiqi H, Yousaf Z. The utility of point of care ultrasonography (POCUS). Ann Med Surg (Lond). 2021 Nov 2;71:102982. doi: 10.1016/j.amsu.2021.102982. eCollection 2021 Nov. No abstract available.

    PubMed 34840746

  • Dall T. et al. The Complexities of Physician Supply and Demand: Projections From 2019 to 2034. Association Of American Medical Collage, 2021.

  • Blanco P, Volpicelli G. Common pitfalls in point-of-care ultrasound: a practical guide for emergency and critical care physicians. Crit Ultrasound J. 2016 Dec;8(1):15. doi: 10.1186/s13089-016-0052-x. Epub 2016 Oct 26.

    PubMed 27783380

  • Smistad E, Ostvik A, Salte IM, Melichova D, Nguyen TM, Haugaa K, Brunvand H, Edvardsen T, Leclerc S, Bernard O, Grenne B, Lovstakken L. Real-Time Automatic Ejection Fraction and Foreshortening Detection Using Deep Learning. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Dec;67(12):2595-2604. doi: 10.1109/TUFFC.2020.2981037. Epub 2020 Nov 24.

    PubMed 32175861

  • Unlu S, Duchenne J, Mirea O, Pagourelias ED, Bezy S, Cvijic M, Beela AS, Thomas JD, Badano LP, Voigt JU; EACVI-ASE Industry Standardization Task Force. Impact of apical foreshortening on deformation measurements: a report from the EACVI-ASE Strain Standardization Task Force. Eur Heart J Cardiovasc Imaging. 2020 Mar 1;21(3):337-343. doi: 10.1093/ehjci/jez189.

    PubMed 31361311

  • Kumar V. There is No Substitute for Human Intelligence. Indian J Crit Care Med. 2021 May;25(5):486-488. doi: 10.5005/jp-journals-10071-23832.

    PubMed 34177163

  • Narang A, Bae R, Hong H, Thomas Y, Surette S, Cadieu C, Chaudhry A, Martin RP, McCarthy PM, Rubenson DS, Goldstein S, Little SH, Lang RM, Weissman NJ, Thomas JD. Utility of a Deep-Learning Algorithm to Guide Novices to Acquire Echocardiograms for Limited Diagnostic Use. JAMA Cardiol. 2021 Jun 1;6(6):624-632. doi: 10.1001/jamacardio.2021.0185.

    PubMed 33599681

  • Liu B.R et al. Emergency Ultrasound Standard Reporting Guidelines. ACEP, 2018. pp. 2-44.

  • Dixon, W.J., Massey, F.J. Introduction to Statistical Analysis. 4th Edition McGraw-Hill, 1983. pp. 105-107

  • Nagata Y, Kado Y, Onoue T, Otani K, Nakazono A, Otsuji Y, Takeuchi M. Impact of image quality on reliability of the measurements of left ventricular systolic function and global longitudinal strain in 2D echocardiography. Echo Res Pract. 2018 Mar;5(1):27-39. doi: 10.1530/ERP-17-0047. Epub 2018 Feb 5.

    PubMed 29432198

  • Russell FM, Herbert A, Ferre RM, Zakeri B, Echeverria V, Peterson D, Wallach P. Development and implementation of a point of care ultrasound curriculum at a multi-site institution. Ultrasound J. 2021 Feb 21;13(1):9. doi: 10.1186/s13089-021-00214-w.

    PubMed 33615390

  • Goldman, L. et al. Echocardiography. Elsevier, Inc, 2020. pp. 253-260

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Diseases and Arrhythmia, Cardiac, run by DiA Imaging Analysis Ltd at 1 site in Israel.

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 6 inclusion and 5 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 Oct 2022. 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 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?

Part 1: Overall agreement of 75% between image quality classification by LVivo IQS and the data tagging by experienced sonographers (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05563701, which also lists 13 linked publications.

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 Oct 2022.

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