NCT07027891招募中不适用
ROMIAE 2 Trial: Randomized Controlled Trial for Managing Suspicious Acute Myocardial Infarction in ED Using AI-ECG
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,670
- 试验地点
- 12
- 主要终点
- 30 Days MACE(Major adverse cardiac events)
研究概览
简要总结
This study is to see whether the AI ECG assisted protocol is as safe and efficacious as conventional protocol in early triage of suspected myocardial infarction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chest pain
- •suspicious of acute myocardial infarction
排除标准
- •Revisit of same symptoms within 1 week
- •traumatic chest pain
- •Pneumothorax
- •Transferred from other hospital diagnosed of AMI
- •Cardiac arrest
- •Chest pain of clearly non-cardiac etiology
- •declined to participate in the study
研究组 & 干预措施
Control group
No Intervention
The patients in control group would be managed with usual care using HEART score in addition to recent acute coronary syndrome guideline.
AI-ECG group
Experimental
The patients in AI-ECG group would be managed with the information of the myocardial infarction risk score in AI-ECG in addition to the usual care.
干预措施: AI-ECG (Device)
结局指标
主要结局
30 Days MACE(Major adverse cardiac events)
时间窗: 30 days
Death, acute myocardial infarction, stroke, target vessel revascularization, stent thrombosis within 30 days from index visit
次要结局
- AI-ECG 30 days MACE prediction performance(30 Days)
- AI-ECG acute myocardial infarction (index visit) discrimination performance(30 Days)
- Medical resources utilization(30 days)
- Medical resources utilization(24 hours)
- Missed acute myocardial infarction at index visit(30 days)
- AI-ECG 30 days MACE prediction performance(30 days)
- AI-ECG acute myocardial infarction (index visit) discrimination performance(30 days)
- Medical resources utilization(7 Days)
研究者
Kyuseok Kim
Professor, MD, PhD
CHA University
研究点 (12)
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