Clinical Indicators and Brain Image Data: a Study Based on Kailuan Cohort

Official title

Clinical Indicators and Brain Image Data: a Cohort Study Based on Kailuan Cohort

Overview

The investigators will analyze the relationship between the medical history, physiological indicators and the cerebral small vessel disease as well as the structural and functional changes of the brain/head and neck organs in a large sample size of subjects (participants), to identify the influencing factors of the occurrence and development of cerebral small vessel disease as well as the structural and functional changes of the brain/head and neck organs, so as to provide objective clues for early intervention of the disease and improve clinical outcomes.

Interventions

• Other No intervention will be applied.
  This is an observational study.

Primary outcome measures

• White matter hyperintensity of the brain measured by MRI (magnetic resonance imaging) [Time frame: every two years up to 30 years]
• microbleeds of the brain measured by MRI (magnetic resonance imaging) [Time frame: every two years up to 30 years]
• Lacunes of the brain measured by MRI (magnetic resonance imaging) [Time frame: every two years up to 30 years]
• Cerebral blood flow measured by MRI (magnetic resonance imaging) [Time frame: every two years up to 30 years]
• Brain volume measured by MRI (magnetic resonance imaging) [Time frame: every two years up to 30 years]
• White matter microstructural integrity of the brain measured by MRI (magnetic resonance imaging) [Time frame: every two years up to 30 years]

Secondary outcome measures (7)

• blood glucose level [Time frame: every two years up to 30 years]
• Cervical vascular ultrasound [Time frame: every two years up to 30 years]
• Fundus color photography of the eyes [Time frame: every two years up to 30 years]
• Fundus optical coherence tomography (OCT) [Time frame: every two years up to 30 years]
• Blood pressure (both Systolic and Diastolic Blood Pressure) [Time frame: every two years up to 30 years]
• BMI (body mass index) [Time frame: every two years up to 30 years]
• Uric acid [Time frame: every two years up to 30 years]

Eligibility criteria

Inclusion criteria

• Age from 18 to 90 years old;
• Comes from the Kailuan Cohort, completed ≥1 visits which the medical history, physiological indicators were measured;
• Without contraindications of CT and MR scan;
• Can cooperate with the measurement of the medical history, physiological indicators and brain imaging.

Exclusion criteria

• Known clinical history with congenital or acquired organic diseases (such as aortic stenosis);
• Known history of drug abuse;
• Pregnant and lactating women; 4. With clinical history of psychiatric diseases (such as schizophrenia).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Ecologic or community

Study locations

China · 2 centers

• Beijing Friendship Hospital, Capital Medical University — Beijing
• Kailuan General Hospital — Tangshan

Publications

• Sun J, Hui Y, Li J, Zhao X, Zhao P, Li X, Chen S, Wu S, Wang Z, Lv H. Association of long-term exposure to lower low-density lipoprotein cholesterol with neuroimaging metrics: A population-based cohort study. Chin Med J (Engl). 2026 Jul 20;139(14):2152-2160. doi: 10.1097/CM9.0000000000004105. Epub 2026 Jun 2. PMID 42230333
• Guo S, Sun J, Zhang Y, Li X, Li J, Zhao X, Zhao P, Chen S, Wu S, Hui Y, Wang Z, Lv H. Association of long-term blood pressure exposure with DTI-ALPS: A population-based cohort study. Brain Res. 2025 Dec 1;1868:149998. doi: 10.1016/j.brainres.2025.149998. Epub 2025 Oct 15. PMID 41106763
• Tong N, Hui Y, Gou SP, Chen LX, Wang XH, Chen SH, Li J, Li XS, Wu YT, Wu SL, Wang ZC, Sun J, Lv H. Clinical information prompt-driven retinal fundus image for brain health evaluation. Mil Med Res. 2025 Aug 6;12(1):47. doi: 10.1186/s40779-025-00630-2. PMID 40770361
• Zhao X, Hui Y, Li J, Shi XQ, Chen S, Lv H, Wu S, Wang Z. Higher Long-Term Visit-to-Visit Blood Pressure Variability Is Associated With Severe Cerebral Small Vessel Disease in the General Population. J Clin Hypertens (Greenwich). 2025 Jan;27(1):e14943. doi: 10.1111/jch.14943. Epub 2024 Nov 16. PMID 39549242
• Zhang T, Lv H, Zhao X, Zeng N, Hui Y, Chen S, Wu N, Xu M, Wu Y, Xing A, Shi H, Zhang S, Liang X, Wang Y, Wu S, Cui L, Wang Z, Liu Y. Serum uric acid is associated with midbrain enlarged perivascular spaces: Results from Multi-modality Medical imaging sTudy bAsed on KaiLuan Study (META-KLS). Prog Neuropsychopharmacol Biol Psychiatry. 2024 Jul 13;133:111000. doi: 10.1016/j.pnpbp.2024.111000. Epub 20 PMID 38580007
• Lv H, Zeng N, Li M, Sun J, Wu N, Xu M, Chen Q, Zhao X, Chen S, Liu W, Li X, Zhao P, Wintermark M, Hui Y, Li J, Wu S, Wang Z. Association between Body Mass Index and Brain Health in Adults: A 16-Year Population-Based Cohort and Mendelian Randomization Study. Health Data Sci. 2024 Mar 15;4:0087. doi: 10.34133/hds.0087. eCollection 2024. PMID 38500551
• Sun J, Hui Y, Li J, Zhao X, Chen Q, Li X, Wu N, Xu M, Liu W, Li R, Zhao P, Wu Y, Xing A, Shi H, Zhang S, Liang X, Wang Y, Lv H, Wu S, Wang Z. Protocol for Multi-modality MEdical imaging sTudy bAsed on KaiLuan Study (META-KLS): rationale, design and database building. BMJ Open. 2023 Feb 10;13(2):e067283. doi: 10.1136/bmjopen-2022-067283. PMID 36764715

Identifiers

NCT: NCT05453877 · 202201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗