St. Olav University Hospital
Trondheim, 7491, Norway
Completed
NCT Number: NCT04580095
Artificial Intelligence for Improved Echocardiography
The purpose of this study is to assess the effect of artificial intelligence algorithms on image quality in echocardiography.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Capacity to consent
Exclusion criteria
- Indication for echocardiographic contrast agents
Treatment and study plan
AI algorithm for apical foreshortening in echocardiography
OtherThe 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.
Primary outcomes
-
Left ventricular apical foreshortening
Time frame: 0 days
Apical foreshortening will be evaluated in a blinded manner by echocardiography experts post hoc. The two study arms will be compared.
Other outcomes
-
Image quality
Time frame: 0 days
Image 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 ventricular size
Time frame: 0 days
Throughout 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 function
Time frame: 0 days
Throughout 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 foreshortening
Time frame: 0 days
Comparison of AI algorithm to detect foreshortening with manual reference
-
Inter-observer variation of left atrial size
Time frame: 0 days
Throughout 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 atrial function
Time frame: 0 days
Throughout 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 atrium
Time frame: 0 days
Cardiac structures as left atrial (LA) lumen, LA wall, LA appendix, mitral valve will be annotated and used as reference.
-
Variation by methodology
Time frame: 0 days
Variation in measurement by the mode of measurement
Sponsors and collaborators
Lead sponsor
Helse Nord-Trøndelag HF
Other
Collaborators
- St. Olavs Hospital
Registry information
Official study title
Technology Revisiting Ultrasound Solutions of Tomorrow - Artificial Intelligence for Improved Echocardiography
Important dates
- Study start
- 2020
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Oct 8, 2020
- Registry last updated
- Apr 14, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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