Clinical trial NCT06431711: Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
Official title: Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Small Vessel Diseases
Retinal Ischemia
Choroid; Injury
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 2400
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The research population for this study consists of patients who have been diagnosed with non-acute ischemic symptoms of Cerebral Small Vessel Disease. Inclusion criteria: Patients with any of the CSVD-related MRI imaging markers; Patients aged old than 35 years; Sign informed consent. Exclusion criteria: Unable to cooperate with examinations; Known dementia; Serious systemic illness; Contraindications for imaging examination; Known retinal diseases. 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Older than 35 years old;
2. Patients who underwent Multimodal MRI with any CSVD imaging marker;
3. Subjects who have signed informed consent.

Exclusion Criteria:

1. Patient who was unable to cooperate with examinations;
2. There are known diseases that may cause or worsen CSVD (brain injury, Down syndrome, Alzheimer's disease, Parkinson's disease, etc.);
3. There are known eye diseases or severe underlying fundus lesions that may impact fundus assessment;
4. Suffering from serious systemic diseases, such as heart, liver, kidney diseases or major mental illnesses;
5. Contraindications for imaging examinations

Exit Criteria:

1. Not meet the inclusion criteria.
2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
3. Any adverse or serious adverse events during the study period judged by investigator

Primary outcomes:
measure: Diagnostic accuracy of fundus OCTA-derived parameters for CSVD
timeFrame: baseline ,6-month, and every 1 year, follow-up time up to 5 years
Secondary outcomes:
measure: The development of total CSVD burden in MRI
timeFrame: baseline ,6-month, and every 1 year, follow-up time up to 5 years
measure: Number of Patients with cerebrovascular events, cardiovascular events, dementia or death
timeFrame: baseline ,6-month, and every 1 year, follow-up time up to 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References: