NCT03542734

Brief Summary

The CIRCLE study is a single-center prospective observational study that enrolled individuals with cerebral small vessel disease (SVD), while free of known dementia or stroke (both cerebral infarction and hemorrhage). The patients will receive neuropsychological testing, retinal digital images and multimodal magnetic resonance imaging (MRI). Blood samples will also be collected. Recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and brain atrophy will be evaluated on both baseline and follow-up brain MRIs. The investigators will explore the predictors of preogression of SVD and cognitive deficits.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
63mo left

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2010Jun 2031

Study Start

First participant enrolled

January 1, 2010

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

21 years

First QC Date

May 20, 2018

Last Update Submit

February 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive state

    Cognitive state based on Mini-mental State Examination

    1year

Study Arms (2)

Individuals with SVDs

Individuals with at least one following imaging finding: recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, or brain atrophy on baseline brain MRI.

Other: multimodal magnetic resonance imaging

Individuals without SVDs

Individuals without any following imaging finding: recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, or brain atrophy on baseline brain MRI.

Other: multimodal magnetic resonance imaging

Interventions

multimodal magnetic resonance imaging included T1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI

Also known as: retinal digital images, neuropsychological testing, Blood samples collection
Individuals with SVDsIndividuals without SVDs

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of certain towns

You may qualify if:

  • Adult (≥40y; no upper limit)
  • Free of known dementia or stroke (both cerebral infarction and hemorrhage)

You may not qualify if:

  • Any MRI contraindications
  • Serious head injury (resulting to loss of consciousness) or received intracranial surgery
  • Suffering from cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, 310000, China

RECRUITING

Related Publications (6)

  • Chen L, Zhong W, Chen H, Zhou Y, Ran W, He Y, Zhang T, Zhu X, Xu X, Yuan C, Lou M. ORIENT Diet: A Potential Neuroprotective Dietary Pattern for Chinese Stroke High-Risk Population. J Am Med Dir Assoc. 2025 Jan;26(1):105331. doi: 10.1016/j.jamda.2024.105331. Epub 2024 Oct 30.

  • Lee DA, Lee HJ, Jo G, Park KM. Choroid plexus volumes in patients with transient global amnesia: A retrospective study. Medicine (Baltimore). 2024 Oct 11;103(41):e40077. doi: 10.1097/MD.0000000000040077.

  • Zhao Y, Zhou Y, Zhou H, Gong X, Luo Z, Li J, Sun J, Lou M, Yan S. Low-density lipoprotein cholesterol, statin therapy, and cerebral microbleeds: The CIRCLE study. Neuroimage Clin. 2023;39:103502. doi: 10.1016/j.nicl.2023.103502. Epub 2023 Aug 22.

  • Zhu X, Zhou Y, Zhong W, Li Y, Wang J, Chen Y, Zhang R, Sun J, Sun Y, Lou M. Higher Functional Connectivity of Ventral Attention and Visual Network to Maintain Cognitive Performance in White Matter Hyperintensity. Aging Dis. 2023 Aug 1;14(4):1472-1482. doi: 10.14336/AD.2022.1206.

  • Zhang K, Zhou Y, Zhang W, Li Q, Sun J, Lou M. MRI-visible perivascular spaces in basal ganglia but not centrum semiovale or hippocampus were related to deep medullary veins changes. J Cereb Blood Flow Metab. 2022 Jan;42(1):136-144. doi: 10.1177/0271678X211038138. Epub 2021 Aug 25.

  • Zhang W, Zhou Y, Wang J, Gong X, Chen Z, Zhang X, Cai J, Chen S, Fang L, Sun J, Lou M. Glymphatic clearance function in patients with cerebral small vessel disease. Neuroimage. 2021 Sep;238:118257. doi: 10.1016/j.neuroimage.2021.118257. Epub 2021 Jun 10.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Cerebral Small Vessel DiseasesRetinal DiseasesCognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEye DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2018

First Posted

May 31, 2018

Study Start

January 1, 2010

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

February 6, 2023

Record last verified: 2023-01

Locations