Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT03542734
Status:
RECRUITING
Last Update Posted:
2023-02-06
First Post:
2018-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2018-05-20', 'studyFirstSubmitQcDate': '2018-05-20', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive state', 'timeFrame': '1year', 'description': 'Cognitive state based on Mini-mental State Examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Small Vessel Diseases', 'Retinopathy', 'Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '39488333', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39465804', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37643520', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '37163435', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34431378', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34118396', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of certain towns', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥40y; no upper limit)\n* Free of known dementia or stroke (both cerebral infarction and hemorrhage)\n\nExclusion Criteria:\n\n* Any MRI contraindications\n* Serious head injury (resulting to loss of consciousness) or received intracranial surgery\n* Suffering from cancer'}, 'identificationModule': {'nctId': 'NCT03542734', 'acronym': 'CIRCLE', 'briefTitle': 'Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Associations of Retinal Microvascular Signs and Brain Imaging Markers With Cognitive Impairment in Patients With Small Vessel Disease', 'orgStudyIdInfo': {'id': 'CIRCLE-CHINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individuals with SVDs', 'description': '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.', 'interventionNames': ['Other: multimodal magnetic resonance imaging']}, {'label': 'Individuals without SVDs', 'description': 'Individuals without any following imaging finding: recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, or brain atrophy on baseline brain MRI.', 'interventionNames': ['Other: multimodal magnetic resonance imaging']}], 'interventions': [{'name': 'multimodal magnetic resonance imaging', 'type': 'OTHER', 'otherNames': ['retinal digital images', 'neuropsychological testing', 'Blood samples collection'], 'description': 'multimodal magnetic resonance imaging included T1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI', 'armGroupLabels': ['Individuals with SVDs', 'Individuals without SVDs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Lou, Ph.D', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '13958007213'}], 'facility': 'The second affiliated hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Min Lou, Ph.D', 'role': 'CONTACT', 'email': 'loumingxc@vip.sina.com', 'phone': '13958007213'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}