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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07727590). StuddyBuddy aggregates publicly available trial information.