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NCT07727590
ER-VISION-AI Study
Conditions: Chest Pain, Dyspnea, Acute Cardiopulmonary Disease, Emergency Department Patients
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1000
Sponsor: Ewha Womans University Mokdong Hospital
Location: Ewha Womans University Mokdong Hospital Seoul
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.
Eligibility Criteria
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 electrocardiogram 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 informed consent
Exclusion Criteria:
* Inability or refusal to provide written informed consent
* 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
Source: ClinicalTrials.gov (NCT07727590). StuddyBuddy aggregates publicly available trial information.