Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of fundus OCTA-derived parameters for CSVD
研究概览
简要总结
Cerebral small-vessel disease (CSVD) is a significant contributor to stroke and dementia, primarily impacting individuals over the age of 60. Its prevalence exceeds 70% in the elderly population, imposing a substantial burden on brain health and the economy. Optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus retinopathy. Current studies have shown that fundus OCTA-derived parameters may have potential in characterizing imaging changes in CSVD. However, the correlation between retinal/choroidal parameters on OCTA and the CSVD imaging markers remains uncertain. FRESH-CSVD is a prospective, observational study that will use fundus OCTA-derived parameters to screen patients with CSVD, explore the relationship between relevant parameters based on OCTA measurements and CSVD, and evaluate the feasibility and clinical value of identification of CSVD through fundus OCTA.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 35 years old;
- •Patients who underwent Multimodal MRI with any CSVD imaging marker;
- •Subjects who have signed informed consent.
排除标准
- •Patient who was unable to cooperate with examinations;
- •There are known diseases that may cause or worsen CSVD (brain injury, Down syndrome, Alzheimer's disease, Parkinson's disease, etc.);
- •There are known eye diseases or severe underlying fundus lesions that may impact fundus assessment;
- •Suffering from serious systemic diseases, such as heart, liver, kidney diseases or major mental illnesses;
- •Contraindications for imaging examinations
- •Exit Criteria:
- •Not meet the inclusion criteria.
- •For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
- •Any adverse or serious adverse events during the study period judged by investigator
结局指标
主要结局
Diagnostic accuracy of fundus OCTA-derived parameters for CSVD
时间窗: baseline ,6-month, and every 1 year, follow-up time up to 5 years
Investigators intend to use these indicators to assess the diagnostic accuracy of fundus OCTA for CSVD: area under the receiver operating characteristic curve (AUROC)
次要结局
- The development of total CSVD burden in MRI(baseline ,6-month, and every 1 year, follow-up time up to 5 years)
- Number of Patients with cerebrovascular events, cardiovascular events, dementia or death(baseline ,6-month, and every 1 year, follow-up time up to 5 years)