Actively Recruiting
Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
Led by Zhejiang Provincial People's Hospital · Updated on 2024-05-29
2400
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cerebral small-vessel disease (CSVD) is a major cause of stroke and dementia, mainly affecting people over 60 years old. It is very common in the elderly, impacting brain health and causing economic challenges. Researchers are exploring how a new imaging technology called optical coherence tomography angiography (OCTA), which captures detailed images of the eye's blood vessels, can help detect and understand CSVD. This observational study will use OCTA to examine the fundus (the back of the eye) in patients with CSVD. The study aims to explore how OCTA-derived measurements relate to brain imaging markers of CSVD and assess if this eye imaging method can effectively identify CSVD. There are no drug or treatment interventions involved. Participants will undergo eye imaging with OCTA and brain scans using MRI at the start and then every six months up to five years. Researchers will track changes in CSVD burden and record any cerebrovascular events, cardiovascular events, dementia, or deaths during follow-up. The main focus is to measure how accurately OCTA parameters can diagnose CSVD over time while monitoring participants' health through regular assessments.
CONDITIONS
Brief Title
Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 35 years old
- Patients who have undergone multimodal MRI showing any cerebral small-vessel disease imaging marker
- Signed informed consent to participate in the study
You will not qualify if you...
- Unable to cooperate with study examinations
- Known diseases that may cause or worsen cerebral small-vessel disease, such as brain injury, Down syndrome, Alzheimer's disease, or Parkinson's disease
- Known eye diseases or severe fundus lesions affecting eye assessment
- Serious systemic diseases including heart, liver, kidney diseases or major mental illnesses
- Contraindications for imaging examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Baseline, 6 months, and every 1 year up to 5 years
Participants undergo fundus optical coherence tomography angiography and MRI imaging to assess cerebral small-vessel disease markers.
Visits at baseline, 6 months, and annually for up to 5 years
Duration - Up to 5 years
Participants are monitored for cerebrovascular events, cardiovascular events, dementia, or death over the follow-up period.
Regular visits coinciding with diagnostic evaluations over up to 5 years
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
S
Sheng Zhang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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