A Study on the Eye-Brain-Kidney Interaction Mechanisms in Chronic Kidney Disease Based on Multimodal Magnetic Resonance Imaging
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Cognitive function assessed by Montreal Cognitive Assessment (MoCA)
Study Overview
Brief Summary
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:
Do 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/OCTA) of their retinas.
Detailed Description
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.
Study Design and Procedures:
The 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.
Assessment Methods and Technical Parameters:
- 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.
- 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.
- 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.
- Clinical and Cognitive Assessments: In addition to standardized scales, remaining serum and plasma samples from participants will be preserved for subsequent biomarker analysis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18-70 years.
- •Patients clinically diagnosed with CKD stages 1-
- •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.
Exclusion Criteria
- •Patients with recent or prior cerebral hemorrhage or cerebral infarction.
- •History of epileptic seizures or psychiatric disorders.
- •Patients with claustrophobia.
- •Pregnant or lactating patients.
- •Presence of other central nervous system diseases (e.g., tumor, trauma).
- •Unstable angina, congestive heart failure (NYHA class III or IV), or acute myocardial infarction.
- •Any systemic or other diseases deemed unsuitable for clinical trial participation.
Outcomes
Primary Outcomes
Cognitive function assessed by Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and 3-year follow-up.
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.
Secondary Outcomes
- Retinal Nerve Fiber Layer (RNFL) Thickness(Baseline and 3-year follow-up.)
- Average Macular Thickness(Baseline and 3-year follow-up.)
- Retinal Specific Lesion Count(Baseline and 3-year follow-up.)
- Retinal Capillary Plexus Vessel Density (VD)(Baseline and 3-year follow-up.)
- Retinal Non-Perfusion Area (NPA)(Baseline and 3-year follow-up.)
- Subfoveal Choroidal Thickness (SCT)(Baseline and 3-year follow-up.)
- Renal Blood Flow (RBF)(Baseline and 3-year follow-up.)
- Estimated Glomerular Filtration Rate (eGFR)(Baseline and 3-year follow-up.)
- Albumin(Baseline and 3-year follow-up.)
- Hemoglobin (Hb)(Baseline and 3-year follow-up.)
- Uric Acid(Baseline and 3-year follow-up.)
- Creatinine(Baseline and 3-year follow-up.)
- High-sensitivity C-Reactive Protein (hs-CRP)(Baseline and 3-year follow-up.)
- Serum Phosphate(Baseline and 3-year follow-up.)
- Serum Calcium(Baseline and 3-year follow-up.)
- Gray Matter Volume (GMV)(Baseline and 3-year follow-up.)
- Amplitude of Low-Frequency Fluctuations (ALFF)(Baseline and 3-year follow-up.)
- Cerebral Blood Flow (CBF)(Baseline and 3-year follow-up.)