Development of Cardiovascular Risk Prediction Tools Based on Artificial Intelligence and Fundus Imaging Technology Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,072
- 主要终点
- Diagnosis of ASCVD at baseline
研究概览
简要总结
This study aims to develop a cardiovascular disease (CVD) screening tool and cardiovascular risk prediction tool based on fundus imaging data with the method of artificial intelligence.
详细描述
This study will establish a cohort of individuals including patients with CVD and participants with high CVD risk, and all the study participants will be follow-up for 1 year. By collecting baseline clinical data, fundus imaging data, and CVD events during the follow up, this study aims to distinguish CVD status based on the fundus imaging data, and explore the association between fundus imaging data and occurence of CVD during the follow up. By using machine learning approach, this study aims to construct a CVD screening tool and CVD prediction tool based on fundus imaging data.
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
- 是
入选标准
- •Three types of participants will be included, which are:
- •Participants with established coronary heart disease, including previously diagnosed myocardial infarction, previous treatment with coronary intervention or coronary artery bypass grafting, coronary artery stenosis ≥50%, or chest pain with objective evidence of myocardial ischemia (myocardial ischemia indicated by stress electrocardiogram or stress imaging)
- •Participants with established stroke.
- •Participants without coronary heart disease or stroke, but are at high risk for CVD, defined as meeting at least two of the following:
- •Men aged ≥ 60 years old, or women aged ≥ 65 years old;
- •Total cholesterol>5.2 mmol/L, or LDL-C>3.4 mmol/L, or HDL-C<1.0 mmol/L;
- •Currently smoking, defined as daily smoking lasting for 1 year or more.
排除标准
- •Participants unable to provide fundus imaging data required for the study due to the following reasons:
- •Permanent blindness, blurred vision, flying mosquito disease, or refractive medium opacity seriously affecting fundus examination, such as severe cataracts, vitreous hemorrhage, etc.
- •Macular edema, severe nonproliferative retinopathy in diabetes, proliferative vitreoretinopathy, radiation ophthalmopathy or retinal vein occlusion
- •Eyeball enucleation, eye deformities, etc.
- •Previous retinal laser therapy, injection therapy for any eye, or history of retinal surgery
- •Photosensitivity, or taking medication that can cause photosensitivity, or currently undergoing photodynamic therapy
- •Unable to cooperate with examination for collection of fundus imaging data
- •Other situations that the participants fail to provide fundus imaging data required for the study
- •Suffering from other serious diseases with an expected survival period of less than one year, such as advanced malignant tumors
- •Unable to adhere to follow-up
- •Other conditions which the researchers consider inappropriate for participants to enroll in the study
结局指标
主要结局
Diagnosis of ASCVD at baseline
时间窗: At enrollment
Whether participants have established ASCVD at baseline
Major cardiovascular events
时间窗: during the 1 year follow-up
a composite of myocardial infarction, coronary or non coronary revascularization surgery, hospitalization or emergency treatment due to new-onset or worsening heart failure, stroke or cardiovascular death
次要结局
未报告次要终点