Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Hierarchical primary endpoint
研究概览
简要总结
The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based ECG interpretation tool improves the early diagnosis and treatment of occlusion myocardial infarction (OMI) in adults presenting with suspected acute coronary syndrome (ACS) who do not meet traditional ST-elevation myocardial infarction (STEMI) criteria.
The main questions it aims to answer are:
- Does AI-assisted ECG interpretation enable more timely identification and treatment of OMI, as defined by earlier initiation of coronary intervention?
- Does AI-assisted diagnosis reduce infarct size, measured by peak high-sensitivity troponin T (hsTnT) levels?
Researchers will compare AI-assisted ECG interpretation to standard care to determine if the AI tool improves clinical outcomes and care timelines.
Participants will:
- Present with symptoms suggestive of ACS but without clear STEMI criteria
- Be randomized 1:1 to either AI-assisted or standard ECG interpretation
- Undergo follow-up assessments for cardiovascular outcomes, including 30-day death, time to treatment of total coronary occlusion, and peak hsTnT levels
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
- Double (Participant, 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
- •Symptoms suspected of ongoing acute myocardial ischemia: Patients presenting with symptoms such as chest pain, dyspnoea, sweating, nausea or vomiting, pain radiating to the shoulder/arm/jaw/back, fatigue, or light-headedness
- •Age: Patients aged 18 years or older.
- •Informed Consent: Patients able to provide informed consent
排除标准
- •Clear diagnosis of ST-segment elevation MI (STEMI) according to managing physicians.
- •Pregnancy or Lactation.
- •Legally incompetent to provide informed consent.
- •Symptoms onset>24 hrs prior to clinical presentation.
研究组 & 干预措施
AI-assisted ECG interpretation
Participants will receive ECG interpretation supported by a CE-marked artificial intelligence (AI) tool (PMcardio, Powerful Medical). The AI output is made available to clinicians in real time, prior to diagnostic or therapeutic decisions, to facilitate earlier identification of occlusion myocardial infarction (OMI) and potentially expedite intervention.
干预措施: AI-assisted ECG interpretation (PMcardio) (Diagnostic Test)
Standard of Care
Participants will receive standard ECG interpretation without AI support. Clinical decisions regarding diagnosis and treatment will follow usual care pathways, without influence from the AI tool. This arm serves as the comparator to evaluate the added value of AI integration.
结局指标
主要结局
Hierarchical primary endpoint
时间窗: 30 days
The primary endpoint of the prospective phase, analysed hierarchically using the unmatched, unstratified win ratio, will be a composite of: * Cardiovascular mortality at 30 days. * Timely treatment of angiographically confirmed TIMI 0-1 occlusions, defined as insertion of the arterial sheath within 120 minutes from randomization. * Time-to-treatment of angiographically confirmed TIMI 0-1 occlusions. * Peak high- hsTnT levels in ng/mL as a surrogate measure of infarct size. Time of coronary intervention will be defined as time from randomisation to insertion of the arterial sheath. Peak hsTnT is defined as the maximum level of hsTnT within 48h from randomization or within 48 hours from intervention if percutaneous coronary intervention took place later than 24 hours from randomization.
次要结局
- Cardiovascular mortality at 30 days(30 days)
- Timely treatment of TIMI 0-1 occlusions(Periprocedural)
- Time-to-treatment of TIMI 0-1 occlusions(Periprocedural)
- Peak hsTnT levels(48 hours from randomization or intervention)
- Major adverse cardiovascular events (MACE) at follow-up(up to 10 years)
- Cardiovascular death at follow-up(up to 10 years)
- Infarct Size(48 hours from randomization or intervention)
- Myocardial infarction at follow-up(up to 10 years)
- Stroke at follow-up(up to 10 years)
- Time from randomization to antithrombotic therapy(periprocedural)
- Time from randomization to coronary angiography(periprocedural)
- Angiographic outcomes (restricted to patients undergoing PCI)(Periprocedural)
- Total time spent in the emergency department post-randomization(periprocedural)
- Length of hospital stay post-randomization(up to 30 days)
- Resource utilization(periprocedural)
- Health economic outcomes(30 days)
- Safety (Serious adverse events)(up to 10 years)
- Diagnostic accuracy of AI algorithm(periprocedural)
- Quality of life (EQ-5D-5L)(up to 30 days)
研究者
Marco Valgimigli
Deputy Chief of Cardiology
Cardiocentro Ticino