## Protocol Section
### Identification Module
**NCT ID:** NCT06431711

**Acronym:** FRESH-CSVD

**Brief Title:** Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease

**Official Title:** Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease

#### Organization Study ID Info
**ID:** KY2024050
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2034-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2029-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-25
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhejiang Provincial People's Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Cerebral Small Vessel Diseases

- Retinal Ischemia

- Choroid; Injury

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 2400

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This does not entail the application of interventions.

**Label:** Individuals with CSVD

### Outcomes Module

#### Primary Outcomes

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

**Measure:** 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

#### Secondary Outcomes

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

**Measure:** The development of total CSVD burden in MRI

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

**Description:** 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.

**Measure:** 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

### Eligibility Module

**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

**Minimum Age:** 35 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhangsheng@hmc.edu.cn

**Name:** Sheng Zhang

**Phone:** +8618758188313

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** zhangsheng@hmc.edu.cn

- **Name:** Sheng Zhang, M.D.

- **Phone:** +8618758188313

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sheng Zhang, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Weitao Yu, B.S.Med

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Zhejiang Provincial People's Hospital

**State:** Zhejiang

**Status:** RECRUITING

**Zip:** 310000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M29437

- Name: Cerebral Small Vessel Diseases

- Relevance: HIGH

- As Found: Cerebral Small Vessel Disease

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059345

- Term: Cerebral Small Vessel Diseases

### Misc Info Module

- Version Holder: 2024-05-31
