NCT06431711 Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease
| NCT ID | NCT06431711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Provincial People's Hospital |
| Condition | Cerebral Small Vessel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,400 participants in total. It began in 2024-04-01 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06431711 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Cerebral Small Vessel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06431711 currently recruiting?
Yes, NCT06431711 is actively recruiting participants. Contact the research team at zhangsheng@hmc.edu.cn for enrollment information.
Where is the NCT06431711 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06431711 clinical trial?
NCT06431711 is sponsored by Zhejiang Provincial People's Hospital. The trial plans to enroll 2,400 participants.