Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly

NCT ID: NCT03542734

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2031-06-30

Brief Summary

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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.

Detailed Description

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Cerebral small vessel disease (SVD) is commonly detected in elderly individuals, and patients with stroke or neurodegenerative disease. Features seen on neuroimaging include recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and brain atrophy. Previous studies indicated that SVD was associated with an increased risk of stroke and stroke recurrence, cognitive deficits, physical disabilities, and mortality. However the pathogenesis of SVD is largely unknown. Little is known about how SVD lesions contribute to neurological or cognitive symptoms, and the association with risk factors. Recent data sugessted concomitant SVDs and retinopathy is associated with a profile of vascular cognitive impairment. In this study, the investigators try to explore the new pathological mechanism of SVD, the new predictors for SVD progression, and the association with cognitive Impairment, based on digital retinal images and brain multimodal imaging technique.

Conditions

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Cerebral Small Vessel Diseases Retinopathy Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

multimodal magnetic resonance imaging

Intervention Type OTHER

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

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.

multimodal magnetic resonance imaging

Intervention Type OTHER

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

Interventions

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multimodal magnetic resonance imaging

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

Intervention Type OTHER

Other Intervention Names

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retinal digital images neuropsychological testing Blood samples collection

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The second affiliated hospital of Zhejiang University

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Lou, Ph.D

Role: CONTACT

13958007213

Facility Contacts

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Min Lou, Ph.D

Role: primary

13958007213

References

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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.

Reference Type DERIVED
PMID: 39488333 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39465804 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37643520 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37163435 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34431378 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34118396 (View on PubMed)

Other Identifiers

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CIRCLE-CHINA

Identifier Type: -

Identifier Source: org_study_id

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