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

NCT06431711 | Recruiting

• 1 other identifier: KY2024050
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Small Vessel Diseases; Retinal Ischemia; Choroid; Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The development of total CSVD burden in MRI

  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

  baseline ,6-month, and every 1 year, follow-up time up to 5 years

Study Arms (1)

Individuals with CSVD

This does not entail the application of interventions.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Wounds and Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Sheng Zhang

CONTACT

+8618758188313; zhangsheng@hmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2034
• Last Updated: May 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)