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NCT Number: NCT03542734

Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The second affiliated hospital of Zhejiang University

Hangzhou, 310000, China

Location status: Recruiting

Location contact

Min Lou, Ph.D

CONTACT

[email protected]

13958007213

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multimodal magnetic resonance imaging

Other

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

Primary outcomes

  1. Cognitive state

    Time frame: 1year

    Cognitive state based on Mini-mental State Examination

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou, Ph.D

CONTACT

[email protected]

13958007213

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: CIRCLE

Important dates

Study start
2010
Primary completion
2030
Study completion
2031
First posted
May 31, 2018
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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