NCT05453877

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Aug 2022Aug 2030

First Submitted

Initial submission to the registry

July 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Expected
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

3 years

First QC Date

July 4, 2022

Last Update Submit

October 27, 2022

Conditions

Brain DiseasesHypertension

Outcome Measures

Primary Outcomes (6)

  • White matter hyperintensity of the brain measured by MRI (magnetic resonance imaging)

    every two years up to 30 years

  • microbleeds of the brain measured by MRI (magnetic resonance imaging)

    every two years up to 30 years

  • Lacunes of the brain measured by MRI (magnetic resonance imaging)

    every two years up to 30 years

  • Cerebral blood flow measured by MRI (magnetic resonance imaging)

    every two years up to 30 years

  • Brain volume measured by MRI (magnetic resonance imaging)

    every two years up to 30 years

  • White matter microstructural integrity of the brain measured by MRI (magnetic resonance imaging)

    every two years up to 30 years

Secondary Outcomes (7)

  • blood glucose level

    every two years up to 30 years

  • Cervical vascular ultrasound

    every two years up to 30 years

  • Fundus color photography of the eyes

    every two years up to 30 years

  • Fundus optical coherence tomography (OCT)

    every two years up to 30 years

  • Blood pressure (both Systolic and Diastolic Blood Pressure)

    every two years up to 30 years

  • +2 more secondary outcomes

Other Outcomes (2)

  • Pulse Wave Velocity, PWV

    every two years up to 30 years

  • Lipoprotein

    every two years up to 30 years

Study Arms (1)

subjects from Kailuan community

1\. Age from 18 to 90 years old; 2. Comes from the Kailuan Cohort, completed ≥1 visits which the medical history, physiological indicators were measured; 3. Without contraindications of CT and MR scan; 4. Can cooperate with the measurement of the medical history, physiological indicators and brain imaging. Subjects with the following conditions should be excluded: 1\. Known clinical history with congenital or acquired organic diseases (such as aortic stenosis); 2. Known history of drug abuse; 3. Pregnant and lactating women; 4. With clinical history of psychiatric diseases (such as schizophrenia).

Other: No intervention will be applied.

Interventions

No intervention will be applied.OTHER

This is an observational study.

subjects from Kailuan community

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects from Kailuan Cohorts

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

NOT YET RECRUITING

Kailuan General Hospital

Tangshan, Hebei, 063000, China

RECRUITING

Related Publications (5)

  • 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: 41106763DERIVED

  • 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: 40770361DERIVED

  • 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 2024 Apr 3.

    PMID: 38580007DERIVED

  • 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: 38500551DERIVED

  • 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: 36764715DERIVED

MeSH Terms

Conditions

Brain DiseasesHypertension

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Zhenchang Wang

CONTACT

+86-13501163497cjr.wzhch@vip.163.com

Jing Li

CONTACT

+86-13693544716lijingxbhtr@163.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 12, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2025

Study Completion (Estimated)

August 1, 2030

Last Updated

October 31, 2022

Record last verified: 2022-10

Locations

CN(2)