NCT07062848进行中（未招募）不适用
The Transthyretin Amyloid Cardiomyopathy Early Detection With Artificial Intelligence (TRACE-AI) Network Study
Yale University12 个研究点 分布在 1 个国家目标入组 1,500,000 人开始时间: 2025年1月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500,000
- 试验地点
- 12
- 主要终点
- To describe the prevalence of probable AI-defined ATTR-CM in defined cohorts of individuals who have undergone standard cardiovascular investigations across a diverse network of US-based health care delivery systems
研究概览
简要总结
This is a multi-center, observational study with the overall objective to examine the scale of under-diagnosis for transthyretin amyloid cardiomyopathy (ATTR-CM) across a broad range of diverse health systems in the US using a fully federated deployment of an artificial intelligence (AI) toolkit of algorithms that detect ATTR-CM on electrocardiography (ECG), point-of-care ultrasound (POCUS), and transthoracic echocardiography (TTE).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Broad inclusion and
排除标准
- •across all 3 objectives:
- •Inclusion Criteria:
- •Age 50-95
- •At least one retrievable ECG and/or 2D echo file (DICOM or equivalent video file) from EHR.
- •Exclusion Criteria:
- •Unavailable key demographics (age, gender, race, ethnicity)
- •Individuals who have opted out of research studies
- •Objective-specific inclusion and exclusion criteria:
- •Primary Objective:
- •Additional exclusion criteria:
- •For subgroup analyses: when evaluating the prevalence of probable ATTR-CM status across demographic groups, we will exclude those with missing baseline demographic information (age, sex, race, geographic region).
- •Secondary Objective 1:
- •Additional inclusion criteria:
- •'Cases': ATTR-CM diagnosis defined by ICD-10 codes (Table 1) OR abnormal bone scintigraphy testing consistent with ATTR-CM OR treatment with an approved transthyretin stabilizer or other ATTR-CM-specific therapy
- •'Controls': any individuals not meeting the case definition. In these participants, we will consider all eligible ECG, POCUS, or TTE studies performed up to 12 months before diagnosis (first date of ICD code appearance, abnormal bone scintigraphy or treatment onset, whichever happened first) and any time after. 'Controls' will be drawn from ECGs, POCUS, or TTE studies performed in individuals not meeting the 'case' criteria above, including individuals who have never undergone dedicating testing or those who underwent e.g., bone scintigraphy, but with negative (or equivocal) findings.
- •Secondary Objective 2:
- •Additional inclusion criteria:
- •Having at least two years of follow-up time between the index test (ECG, POCUS, or TTE) and the date of analysis.
- •Having at least one healthcare encounter every two years across care settings from their first entry into the cohort through death or end of the follow-up period.
结局指标
主要结局
To describe the prevalence of probable AI-defined ATTR-CM in defined cohorts of individuals who have undergone standard cardiovascular investigations across a diverse network of US-based health care delivery systems
时间窗: At enrollment
次要结局
- Validate the diagnostic performance of AI-enabled ECG, POCUS, and TTE algorithms for ATTR-CM(At enrollment)
- To examine the association between the AI-defined probability of ATTR-CM and the incidence of adverse cardiovascular events(At enrollment)
研究者
研究点 (12)
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