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临床试验/NCT07626060
NCT07626060招募中不适用

Diagnostic Accuracy of Large Language Models (GPT-4o and Claude) in HEART Score Calculation and 30-Day MACE Prediction in Emergency Department Chest Pain Patients: A Prospective Observational Validation Study Against Three-Expert Consensus

Marmara University Pendik Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 690 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
690
试验地点
1

研究概览

简要总结

This prospective observational diagnostic accuracy study evaluates whether large language models (LLMs) - GPT-4o (OpenAI, gpt-4o-2024-11-20) and Claude (Anthropic, claude-sonnet-4-6) - can accurately calculate HEART scores from unstructured Turkish clinical notes and predict 30-day major adverse cardiac events (MACE) in emergency department patients presenting with non-traumatic chest pain.

The study will enroll 600 consecutive adult patients. For each patient, the same anonymized data (free-text anamnesis, ECG report text, troponin value, and age) will be independently processed by both LLMs via separate API calls with deterministic settings (temperature=0, JSON format). A three-expert consensus HEART score - derived through blinded independent scoring by three emergency medicine physicians with majority-vote adjudication - serves as the reference standard for agreement analysis. Actual 30-day MACE (all-cause death, AMI Type 1/2/4b, unplanned revascularization) determined via national health database and telephone follow-up serves as the outcome for diagnostic accuracy analysis.

A secondary documentation-quality sub-study will quantify how spontaneously Turkish emergency anamnesis notes capture HEART score parameters.

详细描述

AI SYSTEM SPECIFICATIONS AND PROMPT PROTOCOL Two distinct large language models (LLMs) will be evaluated as index tests: OpenAI GPT-4o (model string: gpt-4o-2024-11-20) and Anthropic Claude (model string: claude-sonnet-4-6). To ensure reproducibility and eliminate stochastic variation, both models will be accessed via standardized API calls using deterministic parameters (temperature = 0, max_tokens = 500, and strict JSON response format). The exact system prompt layout will be locked prior to initialization, and its integrity will be verified using a SHA-256 cryptographic hash. The models will evaluate each patient record independently in zero-shot isolation, with no cross-contamination or conversational history retention between runs.

REFERENCE STANDARD CONSENSUS PROTOCOL The reference standard consists of a structured consensus HEART score established by three independent emergency medicine physicians (each possessing >=3 years of clinical experience and specific training on HEART score criteria). The physicians will review the anonymized clinical charts while remaining strictly blinded to the LLM outputs and the final 30-day MACE outcomes. For each of the 5 HEART components (scored 0, 1, or 2), a majority vote (2/3 agreement) will determine the final component score. In the event of complete disagreement across all three reviewers on a specific component, a fourth independent adjudicator will resolve the tie.

INDETERMINATE RESULTS MANAGEMENT

In strict compliance with STARD-AI 2025 guidelines, cases with missing or uninterpretable parameters within the free-text clinical notes will be classified into predefined indeterminate tiers:

  1. Complete Cases: 0 indeterminate components (eligible for primary diagnostic accuracy analysis).
  2. Partial Indeterminate: Exactly 1 missing component preventing definitive automatic calculation.
  3. Full Indeterminate: >=2 missing components. The proportion of indeterminate classifications will be quantified for both LLMs and evaluated alongside the routine documentation quality of the charts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >=18 years
  • Chief complaint of non-traumatic chest pain at the emergency department
  • Written informed consent obtained from the patient or legally authorized representative
  • Availability for 30-day follow-up (reachable by telephone and/or actively registered in the e-Nabiz national health database)

排除标准

  • Traumatic chest pain etiology
  • ST-elevation myocardial infarction (STEMI) at presentation requiring immediate reperfusion protocol
  • Refusal or subsequent withdrawal of informed consent
  • Inability to complete the mandatory 30-day follow-up period
  • WITHDRAWAL CRITERIA:
  • Patient or representative requests data withdrawal after initial consent
  • Administrative identification of retrospective data entry after enrollment

研究者

发起方
Marmara University Pendik Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emir Ünal

MD, Assistant Professor

Marmara University Pendik Training and Research Hospital

研究点 (1)

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