NCT07398950Enrolling By Invitation不适用
Prospective Evaluation of Artificial Intelligence-enabled Screening for Transthyretin Amyloid Cardiomyopathy (ATTR-CM): TRACE-AI Prospective Study
Yale University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年7月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Performance of the sequential screening approach
研究概览
简要总结
The TRACE-AI Diagnostic Study will evaluate the performance of artificial intelligence (AI) models applied to electrocardiograms (AI-ECG) and echocardiograms (AI-Echo) to identify transthyretin amyloid cardiomyopathy (ATTR-CM) in adults with heart failure. Model performance will be validated through comparison with technetium-99m pyrophosphate (PYP) imaging results.
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
- 否
入选标准
- •Patients 18 years or older with at least one of each component cardiovascular diagnosis testing (ECG and Echo) in the YNHHS.
- •Patients with a diagnosis of HFpEF or HFmrEF
- •Participant from Phase I TRACE-AI Study with AI-ECG and AI-Echo screen in the preceding 36 months
排除标准
- •Patients who have opted out of research studies
- •Patients with cardiac amyloid diagnostic test in the past 36 months
- •Patients with hypertrophic cardiomyopathy or end-stage renal disease
- •Pregnant women
- •Patients unable or unwilling to provide informed consent
- •Non-English speakers and cognitively impaired individuals who are unable to comprehend the consent and the on-screen instructions on the application, which are in English.
结局指标
主要结局
Performance of the sequential screening approach
时间窗: From enrollment through completion of PYP scan at baseline study visit
Measured by the positive predictive value (PPV) of the test for ATTR-CM, based on confirmatory imaging and clinical testing
次要结局
未报告次要终点
研究者
研究点 (2)
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