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CIRCLE: Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03542734
Collaborator
(none)
1,000
Enrollment
1
Location
257.9
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: multimodal magnetic resonance imaging

Detailed Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Associations of Retinal Microvascular Signs and Brain Imaging Markers With Cognitive Impairment in Patients With Small Vessel Disease
Actual Study Start Date :
Jan 1, 2010
Anticipated Primary Completion Date :
Dec 30, 2030
Anticipated Study Completion Date :
Jun 30, 2031

Arms and Interventions

Arm Intervention/Treatment
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
multimodal magnetic resonance imaging included T1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI
Other Names:
  • retinal digital images
  • neuropsychological testing
  • Blood samples collection

    		•
    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
    multimodal magnetic resonance imaging included T1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI
    Other Names:
  • retinal digital images
  • neuropsychological testing
  • Blood samples collection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cognitive state [1year]

      Cognitive state based on Mini-mental State Examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The second affiliated hospital of Zhejiang University Hangzhou China 310000

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT03542734
    Other Study ID Numbers:
    • CIRCLE-CHINA
    First Posted:
    May 31, 2018
    Last Update Posted:
    Mar 23, 2021
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cerebral Small Vessel Diseases
    Retinal Diseases
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Mar 23, 2021