Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly (CIRCLE)

February 2, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

The Associations of Retinal Microvascular Signs and Brain Imaging Markers With Cognitive Impairment in Patients With Small Vessel Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China, 310000
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of certain towns

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive state
Time Frame: 1year
Cognitive state based on Mini-mental State Examination
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2010

Primary Completion (ANTICIPATED)

December 30, 2030

Study Completion (ANTICIPATED)

June 30, 2031

Study Registration Dates

First Submitted

May 20, 2018

First Submitted That Met QC Criteria

May 20, 2018

First Posted (ACTUAL)

May 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRCLE-CHINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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