[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620511":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":71,"studyPopulation":72,"armGroups":67,"interventions":67,"overallOfficials":67,"centralContacts":73,"locations":79,"responsibleParty":96,"collaborators":67,"id":98,"slug":67,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":67,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":110,"studyType":111,"phases":67,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":82,"whyStopped":67,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Beijing Friendship Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":67},[9],{"measure":10,"description":11,"timeFrame":12},"Cognitive function assessed by Montreal Cognitive Assessment (MoCA)","The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool with a total score range of 0 to 30, where higher scores indicate better cognitive function. A score below 26 is indicative of cognitive impairment.","Baseline and 3-year follow-up.",[14,17,20,23,26,29,32,35,38,41,44,47,50,52,55,58,61,64],{"measure":15,"description":16,"timeFrame":12},"Retinal Nerve Fiber Layer (RNFL) Thickness","Thickness of the retinal nerve fiber layer, measured in micrometers (μm) using optical coherence tomography (OCT).",{"measure":18,"description":19,"timeFrame":12},"Average Macular Thickness","The average thickness of the macular region, measured in micrometers (μm) via optical coherence tomography (OCT).",{"measure":21,"description":22,"timeFrame":12},"Retinal Specific Lesion Count","The number of specific lesions (e.g., microaneurysms, hemorrhages) identified in the retina, reported as a count.",{"measure":24,"description":25,"timeFrame":12},"Retinal Capillary Plexus Vessel Density (VD)","The density of blood flow in the retinal capillary networks, expressed as a percentage (%) measured by optical coherence tomography angiography (OCTA).",{"measure":27,"description":28,"timeFrame":12},"Retinal Non-Perfusion Area (NPA)","The total area of retinal capillary non-perfusion, measured in square millimeters (mm²) using optical coherence tomography angiography (OCTA).",{"measure":30,"description":31,"timeFrame":12},"Subfoveal Choroidal Thickness (SCT)","The thickness of the choroid directly beneath the fovea, measured in micrometers (μm) using enhanced-depth imaging optical coherence tomography (EDI-OCT).",{"measure":33,"description":34,"timeFrame":12},"Renal Blood Flow (RBF)","Volume of blood delivered to the kidneys per unit time, measured in milliliters per minute (mL\u002Fmin).",{"measure":36,"description":37,"timeFrame":12},"Estimated Glomerular Filtration Rate (eGFR)","An estimate of the rate at which blood is filtered by the glomeruli of the kidneys, standardized to body surface area and reported in mL\u002Fmin\u002F1.73 m².",{"measure":39,"description":40,"timeFrame":12},"Albumin","Concentration of albumin protein in the blood, measured in grams per liter (g\u002FL), important for assessing nutritional status and liver\u002Fkidney function.",{"measure":42,"description":43,"timeFrame":12},"Hemoglobin (Hb)","Concentration of hemoglobin in the blood, measured in grams per liter (g\u002FL), indicating the oxygen-carrying capacity of red blood cells.",{"measure":45,"description":46,"timeFrame":12},"Uric Acid","Concentration of uric acid in the blood, measured in micromoles per liter (μmol\u002FL), used as a marker for conditions like gout and kidney function.",{"measure":48,"description":49,"timeFrame":12},"Creatinine","Concentration of creatinine in the blood, measured in micromoles per liter (μmol\u002FL), a key indicator of kidney function.",{"measure":51,"description":40,"timeFrame":12},"High-sensitivity C-Reactive Protein (hs-CRP)",{"measure":53,"description":54,"timeFrame":12},"Serum Phosphate","Concentration of inorganic phosphate in the blood, measured in millimoles per liter (mmol\u002FL), important for bone metabolism and cellular energy.",{"measure":56,"description":57,"timeFrame":12},"Serum Calcium","Concentration of calcium in the blood, measured in millimoles per liter (mmol\u002FL), crucial for bone health, nerve function, and blood clotting.",{"measure":59,"description":60,"timeFrame":12},"Gray Matter Volume (GMV)","The volume of gray matter tissue in a specific region of the brain, measured in cubic millimeters (mm³) from structural magnetic resonance imaging (MRI).",{"measure":62,"description":63,"timeFrame":12},"Amplitude of Low-Frequency Fluctuations (ALFF)","A measure of the intensity of regional spontaneous brain activity in the low-frequency range, derived from resting-state functional MRI (fMRI) and expressed in arbitrary units (a.u.).",{"measure":65,"description":66,"timeFrame":12},"Cerebral Blood Flow (CBF)","The volume of blood supplying a given amount of brain tissue per unit time, typically measured in milliliters per 100 grams of tissue per minute (mL\u002F100 g\u002Fmin) using arterial spin labeling (ASL) or similar MRI techniques.",null,{"allocation":67,"interventionModel":67,"interventionModelDescription":67,"primaryPurpose":67,"observationalModel":69,"timePerspective":70,"maskingInfo":67},"COHORT","PROSPECTIVE","This is a prospective, single-center, observational cohort study designed to investigate the multi-system interactions among the eyes, brain, and kidneys in patients with Chronic Kidney Disease (CKD) stages 1-5. The study integrates multimodal imaging, clinical laboratory tests, and neuropsychological assessments to establish a comprehensive \"eye-brain-kidney\" evaluation framework.\n\nStudy Design and Procedures:\n\nThe study plans to enroll CKD patients from Beijing Friendship Hospital, Capital Medical University, between December 2025 and December 2028. All enrolled participants will undergo comprehensive evaluations at two time points: baseline and a 3-year follow-up. Baseline assessments include: medical history collection, neuropsychological scale evaluations (Montreal Cognitive Assessment, Symbol-Digit Modalities Test, Digit Span Test, Hospital Anxiety and Depression Scale), blood tests (complete blood count, biochemistry, and specific biomarkers such as Tau protein and β2-microglobulin), multimodal brain magnetic resonance imaging (MRI), multiparametric kidney MRI, and ocular optical coherence tomography (OCT). The above assessments will be repeated at the 3-year follow-up to observe longitudinal changes in all parameters.\n\nAssessment Methods and Technical Parameters:\n\n1. Brain MRI: A 3.0T MRI scanner will be used to acquire multiple sequences including 3D T1-weighted structural imaging, resting-state functional MRI, arterial spin labeling perfusion imaging, diffusion tensor imaging, quantitative susceptibility mapping, and amide proton transfer-chemical exchange saturation transfer imaging. These will be used to analyze brain structure, perfusion, functional connectivity, and metabolic changes.\n2. Kidney MRI: A 3.0T MRI scanner will be used with sequences such as intravoxel incoherent motion, arterial spin labeling, and T1 mapping to quantitatively assess renal microcirculation perfusion, tissue diffusion characteristics, and the degree of fibrosis.\n3. Ocular Imaging: Optical coherence tomography and angiography will be used to obtain quantitative parameters including retinal nerve fiber layer thickness, macular structure, choroidal thickness, and vessel density in the superficial and deep retinal capillary plexuses.\n4. Clinical and Cognitive Assessments: In addition to standardized scales, remaining serum and plasma samples from participants will be preserved for subsequent biomarker analysis.\n\nQuality Control and Data Management:\n\nA comprehensive quality control plan has been developed and implemented for this study:\n\nData Acquisition QC: Standardized scanning protocols and fixed procedures are used for imaging data acquisition, including the use of specialized earplugs and head fixation pads to reduce noise and motion artifacts. Criteria for data re-acquisition or exclusion are established for subjects with excessive head motion or inability to cooperate.\n\nData Management: Prospective data collection utilizes unified, standardized questionnaires performed by trained research personnel with simultaneous double verification. All data will be anonymized and stored in an encrypted, dedicated database with strict tiered access control to ensure data security and privacy.\n\nProcess and Ethical Oversight: The study protocol, informed consent forms, and other documents have been reviewed and approved by the hospital's Life Ethics Committee. A participant follow-up safeguard mechanism has been established, including follow-up reminders, emergency plans for clinical changes, and documentation of loss to follow-up. The study guarantees participants the right to withdraw unconditionally at any time, with their legitimate rights and interests fully protected.\n\nSample Size and Statistical Analysis:\n\nThe sample size was calculated based on between-group comparisons of the primary outcome measure (MoCA score). Using a one-way ANOVA, with α=0.05, power of 80%, and an effect size f=0.10, the minimum required sample size was calculated to be 1200. Considering a 15% attrition rate, the final planned enrollment is 1500 participants.\n\nStatistical analysis will be performed using SPSS 26.0 and SPM12 software. Continuous data will be described using mean ± standard deviation or median based on normality test results. Between-group comparisons will use ANOVA or non-parametric tests according to data distribution. For multimodal imaging data, voxel-wise between-group comparisons will be conducted, controlling for covariates such as age and sex, with cluster-level FDR correction. Correlation analyses will use Pearson or Spearman correlation, with Bonferroni correction for multiple comparisons. The significance level is set at p \\\u003C 0.05.","The study population will consist of a prospective cohort of adult patients with Chronic Kidney Disease (CKD) recruited from a single clinical center. All participants will be selected from patients attending the Department of Nephrology and other relevant clinics at Beijing Friendship Hospital, Capital Medical University. The primary eligibility criteria include an age range of 18 to 70 years and a clinical diagnosis of CKD at any stage (1 through 5). Key exclusions are applied to ensure patient safety and specificity of the observational findings, primarily concerning conditions that contraindicate MRI procedures or represent significant, unstable comorbid systemic, cardiovascular, or neuropsychiatric diseases. A total of 1500 participants meeting these criteria are planned to be enrolled. Each participant will undergo a comprehensive baseline assessment and a follow-up evaluation at 3 years.",[74],{"name":75,"role":76,"phone":77,"phoneExt":67,"email":78},"Hao Wang","CONTACT","+86 18810643768","wanghao4756@163.com",[80],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Beijing Friendship Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100050","China","CN",{"type":89,"coordinates":90},"Point",[91,92],116.39723,39.9075,{"lat":92,"lon":91},[95],{"name":75,"role":76,"phone":77,"phoneExt":67,"email":78},{"type":97,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100620511",false,"NCT07358572","Eye-Brain-Kidney in CKD","A Study on the Eye-Brain-Kidney Interaction Mechanisms in Chronic Kidney Disease Based on Multimodal Magnetic Resonance Imaging","Inclusion Criteria:\n\n1. Aged 18-70 years.\n2. Patients clinically diagnosed with CKD stages 1-5.\n3. No contraindications for MRI examination (e.g., cardiac pacemaker, claustrophobia, cochlear implant, hearing aid, coronary stents implanted before 2015) and able to complete the MRI scan.\n\nExclusion Criteria:\n\n1. Patients with recent or prior cerebral hemorrhage or cerebral infarction.\n2. History of epileptic seizures or psychiatric disorders.\n3. Patients with claustrophobia.\n4. Pregnant or lactating patients.\n5. Presence of other central nervous system diseases (e.g., tumor, trauma).\n6. Unstable angina, congestive heart failure (NYHA class III or IV), or acute myocardial infarction.\n7. Any systemic or other diseases deemed unsuitable for clinical trial participation.","ALL","18 Years","70 Years",{"count":108,"type":109},1500,"ESTIMATED","3 Years","OBSERVATIONAL","The goal of this observational study is to learn about the interaction between the eyes, brain, and kidneys in adult patients with Chronic Kidney Disease (CKD). The main question it aims to answer is:\n\nDo changes in the brain's network connectivity and the retina's blood vessels correlate with cognitive decline and kidney function in CKD patients? Participants with CKD who are already undergoing clinical care will complete cognitive tests and questionnaires, have non-invasive MRI scans of their brain and kidneys, and undergo non-invasive eye imaging (OCT\u002FOCTA) of their retinas.",[114],"Chronic Kidney Diseases",[116,117],"Multimodal magnetic resonance imaging","Montreal Cognitive Assessment","2026-01-25",{"date":120,"type":121},"2026-01-27","ACTUAL",{"date":123,"type":121},"2025-12-01",{"date":125,"type":109},"2031-12-31",{"name":5,"class":6},1]