Artificial Intelligence for Improved Echocardiography

April 7, 2022 updated by: Helse Nord-Trøndelag HF

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7491
        • St. Olav University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Capacity to consent

Exclusion Criteria:

  • Indication for echocardiographic contrast agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: With AI algorithm
In the "With AI algorithm" arm, the sonographer will perform the echocardiographic exam using the AI algorithm.
Other: AI 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.
No Intervention: Without AI algorithm
In the "Without AI algorithm", the echocardiographic exam will be performed without the use of the AI algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 days
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.
0 days
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.
0 days
Validation of AI algorithm to detect foreshortening
Time Frame: 0 days
Comparison of AI algorithm to detect foreshortening with manual reference
0 days
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.
0 days
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.
0 days
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.
0 days
Variation by methodology
Time Frame: 0 days
Variation in measurement by the mode of measurement
0 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Nord-Trøndelag HF

Collaborators

St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRUST-AI_201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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