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AzTrials

Brain DiseasesNCT05453877

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

An observational study of Brain Diseases and Hypertension, run by Beijing Friendship Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Brain Diseases, Hypertension
How many people
1,000 participants
Where
2 sitesChina
Study dates
1 Aug 2022to 1 Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects from Kailuan Cohorts

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenchang Wang contact

+86-13501163497

cjr.wzhch@vip.163.com

Jing Li contact

+86-13693544716

lijingxbhtr@163.com

China2 sites, 2 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Zhenchang Wang, +86-13501163497, cjr.wzhch@vip.163.com

    Zhenchang Wang

    Not yet recruiting

  • Kailuan General Hospital

    Tangshan, Hebei, 063000

    Ying Hui, +86-15373588526, wyt0086@163.com

    Shouling Wu

    Recruiting

Other trials in China

About this study

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

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.

Being tested
No intervention will be applied.
Medical subject headings
Brain Diseases, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No intervention will be applied.Other

    This is an observational study.

Study groups in NCT05453877
Study groupRoleWhat they receive
subjects from Kailuan community1. 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).
Receives: Other: No intervention will be applied.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: every two years up to 30 years

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

    Measured: every two years up to 30 years

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

    Measured: every two years up to 30 years

  4. Cerebral blood flow measured by MRI (magnetic resonance imaging)

    Measured: every two years up to 30 years

  5. Brain volume measured by MRI (magnetic resonance imaging)

    Measured: every two years up to 30 years

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

    Measured: every two years up to 30 years

Secondary outcomes (7)

  1. blood glucose level

    Measured: every two years up to 30 years

  2. Cervical vascular ultrasound

    Measured: every two years up to 30 years

  3. Fundus color photography of the eyes

    Measured: every two years up to 30 years

  4. Fundus optical coherence tomography (OCT)

    Measured: every two years up to 30 years

  5. Blood pressure (both Systolic and Diastolic Blood Pressure)

    Measured: every two years up to 30 years

  6. BMI (body mass index)

    Measured: every two years up to 30 years

  7. Uric acid

    Measured: every two years up to 30 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05453877
Sponsor's protocol ID
202201
Status last verified
Oct 2022
First submitted
4 Jul 2022
Last updated
31 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 2024 Apr 3.

    PubMed 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.

    PubMed 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.

    PubMed 36764715

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Diseases and Hypertension, run by Beijing Friendship Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhenchang Wang (+86-13501163497, cjr.wzhch@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

White matter hyperintensity of the brain measured by MRI (magnetic resonance imaging) (time frame: every two years up to 30 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05453877, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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