NCT05438576已完成不适用
Screening for Peripartum Cardiomyopathies Using Artificial Intelligence (SPEC-AI) in Nigeria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 1,232
- 试验地点
- 6
- 主要终点
- Left Ventricular Ejection Fraction (LVEF) <50%
研究概览
简要总结
This study will evaluate the effectiveness of an artificial intelligence-enabled ECG (AI-ECG) for cardiomyopathy detection in an obstetric population in Nigeria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently pregnant or within 12 months postpartum
- •Willing and able to provide informed consent
排除标准
- •Complex congenital heart disease (single ventricle physiology or significant shunts with cardiac structural changes)
- •Significant conduction abnormalities (ventricular pacing on recorded ECG, pacemaker dependence, or severely abnormal/bizarre QRS morphology on ECG tracings)
- •Unable or unwilling to provide consent
结局指标
主要结局
Left Ventricular Ejection Fraction (LVEF) <50%
时间窗: 18 months
Number of participants diagnosed with left ventricular ejection fraction (LVEF) \<50% by echocardiography during pregnancy or within 12 months postpartum.
次要结局
- Effectiveness of AI-ECG for Cardiomyopathy Detection in the Intervention Arm for Left Ventricular Ejection Fraction (LVEF) ≤ 35%(18 months)
- Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 40%(18 months)
- Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 45%(18 months)
- Effectiveness AI-ECG for Cardiomyopathy Detection in the Intervention Arm in LVEF < 50%(18 months)
研究者
Demilade A. Adedinsewo
Principal Investigator
Mayo Clinic
研究点 (6)
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