Developing Echocardiography Image Quality Management System Based on Deep Learning

February 21, 2023 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Echocardiography Image Quality Management System Based on Deep Learning: A Single-center Prospective Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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 inclusion criteria: Patients with standardized TTE view segmentation; The exclusion criteria: Patients with incomplete standard segmentations. 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 echocardiography image quality management system was performed on the rest 500 patients and improved.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Affiliated Drum Tower Hospital of Nanjing University Medical School
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with standardized TTE views

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Standardized View Group
The echocardiography view images of patients in this group are standardized.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the score of PSAX view
Time Frame: 12 months
the score of PSAX view by the echocardiography image quality management system
12 months
the score of apical view
Time Frame: 12 months
the score of apical view by the echocardiography image quality management system
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Southeast University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 1, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-337-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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