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

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05453877
Collaborator
KaiLuan General Hospital (Other)
1,000
2
96
500
5.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention will be applied.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Clinical Indicators and Brain Image Data: a Cohort Study Based on Kailuan Cohort
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2030

Arms and Interventions

Arm Intervention/Treatment
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.
This is an observational study.

Outcome Measures

Primary Outcome Measures

  1. Blood pressure (both Systolic and Diastolic Blood Pressure) [every two years up to 30 years]

  2. BMI (body mass index) [every two years up to 30 years]

Secondary Outcome Measures

  1. blood glucose level [every two years up to 30 years]

  2. Cervical vascular ultrasound [every two years up to 30 years]

  3. Abdominal ultrasound [every two years up to 30 years]

  4. White matter hyperintensity of the brain measured by MRI (magnetic resonance imaging) [every two years up to 30 years]

  5. microbleeds of the brain measured by MRI (magnetic resonance imaging) [every two years up to 30 years]

  6. Lacunes of the brain measured by MRI (magnetic resonance imaging) [every two years up to 30 years]

  7. Brain volume measured by MRI (magnetic resonance imaging) [every two years up to 30 years]

  8. White matter microstructural integrity of the brain measured by MRI (magnetic resonance imaging) [every two years up to 30 years]

  9. Cerebral blood flow measured by MRI (magnetic resonance imaging) [every two years up to 30 years]

  10. Fundus color photography of the eyes [every two years up to 30 years]

  11. Fundus optical coherence tomography (OCT) [every two years up to 30 years]

Other Outcome Measures

  1. Pulse Wave Velocity, PWV [every two years up to 30 years]

  2. Lipoprotein [every two years up to 30 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  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.

Exclusion Criteria:
  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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050
2 Kailuan General Hospital Tangshan Hebei China 063000

Sponsors and Collaborators

  • Beijing Friendship Hospital
  • KaiLuan General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wang, Zhenchang, Professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT05453877
Other Study ID Numbers:
  • 202201
First Posted:
Jul 12, 2022
Last Update Posted:
Jul 13, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2022