NCT05633732

Brief Summary

To develop an echocardiography image quality management system based on deep learning to achieve objective and accurate automatic echocardiography image quality control. A total of 2000 patients performing transthoracic echocardiography were prospectively enrolled in the Department of Ultrasound Medicine of the Affiliated Drum Tower Hospital with Medical School of Nanjing University. The data of 8 TTE view segmentations were collected, including the views of the parasternal long axis of the left ventricle (PLAX\_LV), parasternal short axis of the large vessel level (PSAX\_GV), parasternal short axis of the mitral valve level (PSAX\_MV), parasternal short axis of the papillary muscle level (PSAX\_PM), parasternal short axis of the apical level (PSAX\_AP), apical four cavity (A4C), apical three cavity (A3C), apical two cavity (A2C). The data of 1500 patients were used as the training set, and the rest were used as the validation set. These video data were classified into corresponding view segmentations and analyzed by the Video Swin Transformed Model. Then, the scoring module of different view segmentations combined key frame extraction, image segmentation, video target recognition and video classification model were established. At the same time, the scores achieved by the automatic echocardiography image assessment system were compared with the artificial score. By constantly correcting and learning and eventually building an primary automated grading system. At last, the automatic echocardiography image assessment system was constructed and performed on the rest 500 patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

December 30, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 23, 2023

Status Verified

September 1, 2022

Enrollment Period

2 years

First QC Date

November 21, 2022

Last Update Submit

February 21, 2023

Conditions

Keywords

EchocardiographyQuality Management SystemDeep learningArtificial Intelligence

Outcome Measures

Primary Outcomes (2)

  • the score of PSAX view

    the score of PSAX view by the echocardiography image quality management system

    12 months

  • the score of apical view

    the score of apical view by the echocardiography image quality management system

    12 months

Study Arms (1)

Standardized View Group

The echocardiography view images of patients in this group are standardized.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with standardized TTE views

You may qualify if:

  • aged ≥18years, gender unlimited;
  • Patients with standardized TTE views;
  • Subjects participated in the study voluntarily and signed informed consent;

You may not qualify if:

  • patients wirh incomplete standard TTE views;
  • patients with poor sound transmission conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (4)

  • Thiebaut R, Thiessard F; Section Editors for the IMIA Yearbook Section on Public Health and Epidemiology Informatics. Artificial Intelligence in Public Health and Epidemiology. Yearb Med Inform. 2018 Aug;27(1):207-210. doi: 10.1055/s-0038-1667082. Epub 2018 Aug 29.

    PMID: 30157525BACKGROUND
  • Sengupta PP, Shrestha S. Machine Learning for Data-Driven Discovery: The Rise and Relevance. JACC Cardiovasc Imaging. 2019 Apr;12(4):690-692. doi: 10.1016/j.jcmg.2018.06.030. Epub 2018 Dec 12. No abstract available.

    PMID: 30553684BACKGROUND
  • Ueda D, Shimazaki A, Miki Y. Technical and clinical overview of deep learning in radiology. Jpn J Radiol. 2019 Jan;37(1):15-33. doi: 10.1007/s11604-018-0795-3. Epub 2018 Dec 1.

    PMID: 30506448BACKGROUND
  • Madani A, Arnaout R, Mofrad M, Arnaout R. Fast and accurate view classification of echocardiograms using deep learning. NPJ Digit Med. 2018;1:6. doi: 10.1038/s41746-017-0013-1. Epub 2018 Mar 21.

    PMID: 30828647BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 1, 2022

Study Start

December 30, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 23, 2023

Record last verified: 2022-09

Locations