NCT04814680已完成不适用
A Non-Interventional Pilot Study to Evaluate A Machine-Learning Algorithm for Prediction of Blood Pressure, Glycated Haemoglobin and Estimated Glomerular Filtration Rate From Digital Retinal Images
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- To assess successful use of methodology for retinal image acquisition, BP (ABPM or manual), HbA1C (laboratory based or point of care test) and e-GFR measurement.
研究概览
简要总结
This is a non-interventional pilot study with the following objectives:
- Establish scalable methodology for collection of retinal images, blood pressure (BP) and laboratory-based assessments
- Compare the results of a machine-learning algorithm in predicting BP, glycated haemoglobin (HbA1c) and estimated glomerular filtration rate (eGFR) from digital retinal images with clinical and laboratory-based measures
- Determine the required sample size needed to support a future study to fully validate the machine-learning algorithm
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 35 years of age, at the time of signing the informed consent.
- •With or without DM (at least 50% of participants will have an HbA1c ≥ 6.5%* and/or a known diagnosis of DM)
- •Male or female (at least 40% of participants must be male, and at least 40% must be female)
- •Capable of giving signed informed consent as described in Appendix A
排除标准
- •As judged by the investigator, any evidence of a medical condition which in the investigator's opinion makes it undesirable for the participant to participate in the study for example, but not limited to, if a participant is critically unwell or requiring ongoing emergency treatment
- •Any known eye condition that may preclude clear imaging of the retina for example; cataracts
- •Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- •Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
- •Previous enrolment in the present study with the exception of roll-in participants who may be re-screened and re-enrolled.
结局指标
主要结局
To assess successful use of methodology for retinal image acquisition, BP (ABPM or manual), HbA1C (laboratory based or point of care test) and e-GFR measurement.
时间窗: up to 66 day
Proportion of participants with completed study procedures and interpretable results including both retinal images, systolic and diastolic BP (ABPM or manual), HbA1c (laboratory based or point of care test) and eGFR at Visit 1
次要结局
未报告次要终点
研究者
研究点 (1)
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