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Artificial Intelligence for Improved Echocardiography

Technology Revisiting Ultrasound Solutions of Tomorrow - Artificial Intelligence for Improved Echocardiography

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04580095
Enrollment
88
Registered
2020-10-08
Start date
2020-09-29
Completion date
2021-06-30
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Brief summary

The purpose of this study is to assess the effect of artificial intelligence algorithms on image quality in echocardiography.

Detailed description

The study population will be recruited from appointed patients at the Clinic of Cardiology, St. Olavs Hospital. After being informed about the study, all patients giving informed consent and meeting the eligibility requirements will undergo their standard clinical echocardiographic exam performed by a sonographer at the clinic. Two additional examinations will then be performed by a different sonographer and an expert cardiologist, respectively. In one of the study arms the sonographer randomized to perform the second exam will use the AI algorithm (intervention).

Interventions

OTHERAI algorithm for apical foreshortening in echocardiography

The algorithm is based on artificial intelligence, giving the sonographer performing the echocardiographic exam real-time feedback on left ventricular apical foreshortening.The algorithm is developed using deep learning techniques by technologists at the Department of Circulation and Medical Imaging, NTNU.

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Helse Nord-Trøndelag HF
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Capacity to consent

Exclusion criteria

* Indication for echocardiographic contrast agents

Design outcomes

Primary

MeasureTime frameDescription
Left ventricular apical foreshortening0 daysApical foreshortening will be evaluated in a blinded manner by echocardiography experts post hoc. The two study arms will be compared.

Other

MeasureTime frameDescription
Inter-observer variation of left ventricular size0 daysThroughout this study, the sonographers and expert cardiologist will perform measurements based on their individual echocardiographic images. Differences in measurements will be evaluated to determine inter-observer variation between sonographers and cardiologists.
Inter-observer variation of left ventricular function0 daysThroughout this study, the sonographers and expert cardiologist will perform measurements based on their individual echocardiographic images. Differences in measurements will be evaluated to determine inter-observer variation between sonographers and cardiologists.
Validation of AI algorithm to detect foreshortening0 daysComparison of AI algorithm to detect foreshortening with manual reference
Image quality0 daysImage quality will be evaluated in a blinded manner by echocardiography experts post hoc. A standardized scoring system for image quality in echocardiography developed locally will be utilized for evaluation with score 1-6, where 1 is minimum and 6 is maximum score. The two study arms will be compared.
Inter-observer variation of left atrial function0 daysThroughout this study, the sonographers and expert cardiologist will perform measurements based on their individual echocardiographic images. Differences in measurements will be evaluated to determine inter-observer variation between sonographers and cardiologists.
Development of AI algorithm for real-time assessment of left atrium0 daysCardiac structures as left atrial (LA) lumen, LA wall, LA appendix, mitral valve will be annotated and used as reference.
Variation by methodology0 daysVariation in measurement by the mode of measurement
Inter-observer variation of left atrial size0 daysThroughout this study, the sonographers and expert cardiologist will perform measurements based on their individual echocardiographic images. Differences in measurements will be evaluated to determine inter-observer variation between sonographers and cardiologists.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026