CLAiR Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 942
- 试验地点
- 1
- 主要终点
- Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
研究概览
简要总结
This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two different retinal image camera models.
详细描述
This is a prospective observational clinical study to collect retinal images and clinical biomarker data in order to analyze the performance of the CLAiR SaMD compared to the reference PCE risk score. CLAiR is a deep learning (DL) model that uses retinal photographs and limited demographic data to classify an individual's risk of developing ASCVD over the next 10 years as elevated (≥7.5%) or non-elevated (<7.5%). For validation, the output of the algorithm can be directly compared to the PCE output, a widely accepted algorithm used by Healthcare Providers to predict ASCVD risk in patients.
The primary hypothesis is that the CLAiR SaMD can achieve high sensitivity and specificity in the binary determination of Yes/No elevated ASCVD risk with PCE risk score ≥7.5% as the reference standard.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 40-75 years
- •Participants must be capable of providing informed consent, demonstrating understanding of the study details, and willingly sign a consent form or verbally confirm their consent in the presence of a witness.
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Known history of atherosclerotic cardiovascular disease, including stroke, heart attack, coronary artery surgery, or stenting
- •Current use of cholesterol-lowering medication, such as a statin
- •A person who has (in at least one eye):
- •Persistent vision impairment: legally blind when wearing current driving glasses or known VA<20/400
- •Known pathological myopia
- •Previous treatment or currently under the care for a retinal disease by a specialist (e.g., ophthalmologist)
结局指标
主要结局
Demonstrate that CLAiR can accurately identify elevated ASCVD risk as determined by PCE score.
时间窗: through study completion, an average of 6 months
Sensitivity and Specificity of CLAiR binary elevated risk classification (PCE ≥ 7.5% Y/N) against the reference standard of PCE ≥ 7.5%
次要结局
未报告次要终点