Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Small Vessel Diseases, Retinal Ischemia, Choroid; Injury. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Diagnostic accuracy of fundus OCTA-derived parameters for CSVD [Time frame: baseline ,6-month, and every 1 year, follow-up time up to 5 years]
Secondary outcome measures (2)
- The development of total CSVD burden in MRI [Time frame: 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 [Time frame: baseline ,6-month, and every 1 year, follow-up time up to 5 years]
Eligibility criteria
Inclusion criteria
- Older than 35 years old;
- Patients who underwent Multimodal MRI with any CSVD imaging marker;
- Subjects who have signed informed consent.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Zhejiang Provincial People's Hospital — Hangzhou
Identifiers
NCT: NCT06431711 · KY2024050