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NCT Number: NCT06431711

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

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.

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Key information

Conditions

Cerebral Small Vessel Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Choroid; Injury Nervous System Diseases Retinal Ischemia Vascular Diseases Wounds and Injuries

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Sheng Zhang, M.D.

CONTACT

[email protected]

+8618758188313

Sheng Zhang, M.D.

PRINCIPAL_INVESTIGATOR

Weitao Yu, B.S.Med

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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:

  • 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

Treatment and study plan

Primary outcomes

  1. Diagnostic accuracy of fundus OCTA-derived parameters for CSVD

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

    Investigators intend to use these indicators to assess the diagnostic accuracy of fundus OCTA for CSVD: area under the receiver operating characteristic curve (AUROC)

Secondary outcomes

  1. The development of total CSVD burden in MRI

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

    Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points

  2. Number of Patients with cerebrovascular events, cardiovascular events, dementia or death

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Zhang

CONTACT

[email protected]

+8618758188313

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Acronym: FRESH-CSVD

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
May 29, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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