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NCT Number: NCT05453877

Clinical Indicators and Brain Image Data: a 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.

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Key information

Conditions

Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Hypertension Nervous System Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No intervention will be applied.

Other

This is an observational study.

Primary outcomes

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

    Time frame: every two years up to 30 years

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

    Time frame: every two years up to 30 years

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

    Time frame: every two years up to 30 years

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

    Time frame: every two years up to 30 years

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

    Time frame: every two years up to 30 years

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

    Time frame: every two years up to 30 years

Secondary outcomes

  1. blood glucose level

    Time frame: every two years up to 30 years

  2. Cervical vascular ultrasound

    Time frame: every two years up to 30 years

  3. Fundus color photography of the eyes

    Time frame: every two years up to 30 years

  4. Fundus optical coherence tomography (OCT)

    Time frame: every two years up to 30 years

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

    Time frame: every two years up to 30 years

  6. BMI (body mass index)

    Time frame: every two years up to 30 years

  7. Uric acid

    Time frame: every two years up to 30 years

Other outcomes

  1. Pulse Wave Velocity, PWV

    Time frame: every two years up to 30 years

  2. Lipoprotein

    Time frame: every two years up to 30 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Li

CONTACT

[email protected]

+86-13693544716

Zhenchang Wang

CONTACT

[email protected]

+86-13501163497

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • KaiLuan General Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2030
First posted
Jul 12, 2022
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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