NCT04996381

Brief Summary

The investigators will develop an artificial intelligence model to predict left ventricular ejection fraction using chest radiographic images and transthoracic echocardiography data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

August 4, 2021

Last Update Submit

September 12, 2022

Conditions

Chest X-ray for Clinical Evaluation

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Ejection Fraction < 40%

    Evaluate the performance of chest X-ray based artificial intelligence algorithms to identify individuals with reduced ejection fraction (\<40%)

    Within two weeks of chest X-ray

Interventions

Scanning Chest X-rays and performing AI algorithms on imagesDIAGNOSTIC_TEST

Chest X-Rays; AI CNNs; Results

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing a transthoracic echocardiogram will be enrolled.

You may qualify if:

  • Adults who are 20 years and older
  • Patient who visited the emergency room or outpatient clinic due to dyspnea and chest pain

You may not qualify if:

  • Patient refusal
  • Uncertain radiographs or transthoracic echocardiography
  • Uncertain tests results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongin Severance Hospital

Yŏngin, Giheung-gu, 16995, South Korea

Location

Study Officials

  • In Hyun Jung, MD, PhD

    Yongin Severance Hospital, Yonsei University College of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD.

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 9, 2021

Study Start

March 1, 2022

Primary Completion

June 30, 2022

Study Completion

September 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

KR(1)