ClinicalTrials.gg
Not yet recruitingNCT07727590ER-VISION-AIUpdated Jul 27, 2026

ER-VISION-AI Study

An interventional study of Generative Pre-trained Transformer (GPT)-assisted multimodal visual language model (VLM) diagnostic support and Conventional emergency department diagnostic evaluation in Chest Pain, Dyspnea and Acute Cardiopulmonary Disease, sponsored by Ewha Womans University Mokdong Hospital. Not yet recruiting at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Ewha Womans University Mokdong Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Prospective, multicenter, randomized, open-label, blinded-endpoint (PROBE-like) clinical trial evaluating whether physician-supervised Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support improves diagnostic concordance in emergency department patients presenting with acute cardiopulmonary symptoms.

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Conditions studied

  • Chest Pain
  • Dyspnea
  • Acute Cardiopulmonary Disease
  • Emergency Department Patients

Keywords

  • Artificial intelligence
  • Large language model
  • Emergency department
  • Electrocardiography
  • Chest radiography
  • Multimodal AI
  • Clinical decision support
  • Randomized controlled trial
03

In context

Chest Pain

388 studies on the registry are indexed under Chest Pain; 64 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 129 across 204 interventional studies indexed under Chest Pain.

Browse Chest Pain studies →

Lead sponsor

Ewha Womans University Mokdong Hospital is the lead sponsor of 28 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Presentation to a participating emergency department with acute cardiopulmonary symptoms, including chest pain, dyspnea, palpitations, syncope, dizziness, or fever accompanied by cardiopulmonary symptoms
  • Performance of both a standard 12-lead and chest radiography during the initial emergency department evaluation
  • Availability of initial clinical assessment, vital signs, laboratory findings, and all mandatory clinical information required for the multimodal AI workflow
  • Expected emergency department observation or hospital admission for at least 24 hours
  • Ability and willingness to provide written

Exclusion criteria

Exclusion Criteria:

  • Inability or refusal to provide written
  • Requirement for immediate life-saving intervention that precludes completion of the study workflow
  • Death before completion of the initial emergency department diagnostic assessment
  • Electrocardiographic quality insufficient for reliable physician or Artificial intelligence (AI) interpretation
  • Chest radiographic quality insufficient for reliable physician or Artificial intelligence (AI) interpretation
  • Cardiac pacing rhythm
  • Missing mandatory clinical information required for the multimodal Artificial intelligence (AI) workflow
  • Previous enrollment in the ER-VISION-AI trial
  • Inability to establish a blinded adjudicated reference diagnosis
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    GPT-assisted multimodal visual language model (VLM) diagnostic strategy

    Participants receive physician-supervised Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support integrating electrocardiography, chest radiography, structured clinical information, laboratory findings, vital signs, and relevant medical history. Treating physicians remain responsible for all diagnostic and therapeutic decisions.

    Diagnostic Test: Generative Pre-trained Transformer (GPT)-assisted multimodal visual language model (VLM) diagnostic support

  • Active comparator
    Conventional physician-guided diagnostic strategy

    Participants undergo standard emergency department diagnostic evaluation according to routine clinical practice without Generative Pre-trained Transformer (GPT)-assisted diagnostic support.

    Diagnostic Test: Conventional emergency department diagnostic evaluation

Interventions

  • Diagnostic testGenerative Pre-trained Transformer (GPT)-assisted multimodal visual language model (VLM) diagnostic support

    A Generative Pre-trained Transformer (GPT)-based multimodal visual language model integrates electrocardiograms, chest radiographs, structured clinical information, laboratory findings, vital signs, and relevant clinical history to generate diagnostic suggestions and differential diagnoses for physician-supervised clinical decision support.

  • Diagnostic testConventional emergency department diagnostic evaluation

    Routine emergency department diagnostic evaluation performed according to standard clinical practice without AI-assisted diagnostic support.

06

What researchers measure

Primary outcomes

  1. Diagnostic concordance between the final emergency department diagnosis and the blinded adjudicated reference diagnosis established at hospital discharge.

    Diagnostic concordance between the treating physician's final emergency department diagnosis and the blinded adjudicated reference diagnosis based on the prespecified principal diagnostic category.

    Time frame: During the index hospitalization, up to hospital discharge (average 3 days)

Secondary outcomes

  1. Diagnostic concordance after Generative Pre-trained Transformer (GPT)-assisted diagnostic support

    Diagnostic concordance between the physician's final emergency department diagnosis after Generative Pre-trained Transformer (GPT)-assisted multimodal diagnostic support and the blinded adjudicated reference diagnosis in participants assigned to the intervention group.

    Time frame: During the index emergency department visit (average 6 hours)

  2. Time from emergency department presentation to final diagnosis

    Time required from emergency department presentation until establishment of the physician's final emergency department diagnosis.

    Time frame: During the index emergency department visit (average 6 hours)

  3. Diagnostic reclassification after Generative Pre-trained Transformer (GPT)-assisted evaluation

    Frequency of changes between the physician's initial working diagnosis and the final emergency department diagnosis after review of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations.

    Time frame: During the index emergency department visit (average 6 hours)

  4. Physician diagnostic confidence

    Physician-reported diagnostic confidence recorded before and after Generative Pre-trained Transformer (GPT)-assisted diagnostic support using the prespecified study assessment scale.

    Time frame: During the index emergency department visit (average 6 hours)

  5. Physician acceptance of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations

    Frequency of physician acceptance, modification, or rejection of Generative Pre-trained Transformer (GPT)-generated diagnostic recommendations in the intervention group.

    Time frame: During the index emergency department visit (average 6 hours)

  6. Emergency department disposition accuracy

    Accuracy of emergency department disposition decisions, including discharge, hospital admission, or intensive care unit admission, compared with the adjudicated reference diagnosis.

    Time frame: Up to hospital discharge (average 3 days)

  7. Emergency department length of stay

    Length of stay in the emergency department measured from patient presentation until emergency department discharge or hospital admission.

    Time frame: Up to hospital discharge (average 3 days)

  8. Hospital length of stay

    Total duration of hospitalization from admission until hospital discharge.

    Time frame: Up to hospital discharge (average 3 days)

  9. In-hospital mortality

    All-cause mortality occurring during the index hospitalization.

    Time frame: Up to hospital discharge (average 3 days)

  10. 30-day all-cause mortality

    All-cause mortality occurring within 30 days after the index emergency department visit.

    Time frame: 30 days

  11. 30-day emergency department revisit

    Revisit to any emergency department for any cause within 30 days after the index emergency department visit.

    Time frame: 30 days

  12. 30-day hospital readmission

    Hospital readmission for any cause within 30 days after discharge from the index hospitalization.

    Time frame: 30 days

07

Study locations

1 site
08

References and documents

Publications

  • Lopez-Puerta JM, Fernandez-Marin MR, Martin Benlloch JA, Lorente R. Spinal osteoid osteoma recurring as an aggressive osteoblastoma. Neurocirugia (Engl Ed). 2020 May-Jun;31(3):146-150. doi: 10.1016/j.neucir.2019.06.002. Epub 2019 Sep 2. English, Spanish. PubMed 31488355 ↗
  • ANCA-associated vasculitis. Nat Rev Dis Primers. 2020 Aug 27;6(1):72. doi: 10.1038/s41572-020-0212-y. No abstract available. PubMed 32855427 ↗
  • Kim TH, Kim CH, Choi SG. Radiation-induced angiosarcoma (RIAS) of the maxilla: a case report. J Korean Assoc Oral Maxillofac Surg. 2020 Aug 31;46(4):288-291. doi: 10.5125/jkaoms.2020.46.4.288. PubMed 32855377 ↗
  • Li R, Chen X, Wang Y. Adverse events analysis of Relugolix (Orgovyx(R)) for prostate cancer based on the FDA Adverse Event Reporting System (FAERS). PLoS One. 2024 Oct 22;19(10):e0312481. doi: 10.1371/journal.pone.0312481. eCollection 2024. PubMed 39436909 ↗
  • Asravor RK. Uncovering the forgotten story of the impact of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome on economic growth in Ghana: A gender analysis. Int J Health Plann Manage. 2023 Sep;38(5):1495-1509. doi: 10.1002/hpm.3675. Epub 2023 Jun 23. PubMed 37353922 ↗
  • Shakiba M, Nazemipour M, Mansournia N, Mansournia MA. Protective effect of intensive glucose lowering therapy on all-cause mortality, adjusted for treatment switching using G-estimation method, the ACCORD trial. Sci Rep. 2023 Apr 10;13(1):5833. doi: 10.1038/s41598-023-32855-3. PubMed 37037931 ↗
  • Topol EJ. High-performance medicine: the convergence of human and artificial intelligence. Nat Med. 2019 Jan;25(1):44-56. doi: 10.1038/s41591-018-0300-7. Epub 2019 Jan 7. PubMed 30617339 ↗
  • Hsu HW, Chiu MC, Shoemaker D, Yang CS. Viral infections in fire ants lead to reduced foraging activity and dietary changes. Sci Rep. 2018 Sep 10;8(1):13498. doi: 10.1038/s41598-018-31969-3. PubMed 30202033 ↗

Individual participant data

Plan to share: Undecided — The investigators have not yet determined whether de-identified individual participant data (IPD), including the analyzable dataset and supporting documentation, will be shared with researchers outside the study team. A final decision will be made after completion of the study, taking into consideration institutional policies, participant privacy, ethical requirements, and applicable regulations.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07727590
Lead sponsor
Ewha Womans University Mokdong Hospital
Collaborators
Ewha Womans University Seoul Hospital
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jul 27, 2026

Study contacts

Yeji Kim, PhD
Contact
lexie6169@gmail.com
+82-10-2724-7740

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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