Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease

Cerebral Small Vessel Diseases Clinical Trial

— FRESH-CSVD  

Official title:

Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431711
• Other study ID #: KY2024050
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: March 31, 2034

Study information

• Verified date: April 2024
• Source: Zhejiang Provincial People's Hospital
• Contact: Sheng Zhang
• Phone: +8618758188313
• Email: zhangsheng[@]hmc.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: March 31, 2034
• Est. primary completion date: March 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Retinal Ischemia

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of fundus OCTA-derived parameters for CSVD	Investigators intend to use these indicators to assess the diagnostic accuracy of fundus OCTA for CSVD: area under the receiver operating characteristic curve (AUROC)	baseline ,6-month, and every 1 year, follow-up time up to 5 years
Secondary	The development of total CSVD burden in MRI	Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points	baseline ,6-month, and every 1 year, follow-up time up to 5 years
Secondary	Number of Patients with cerebrovascular events, cardiovascular events, dementia or death	Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA) and cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction.; Using the Chinese version of the MMSE scale, dementia is defined based on different levels of education (= 22, = 23, = 24, = 26 points for illiteracy, primary school, junior high school, and university).; Death included any reason caused death.	baseline ,6-month, and every 1 year, follow-up time up to 5 years