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

Recruiting

• Conditions: Brain Diseases; Hypertension
• Interventions: Other: No intervention will be applied.

• Registration Number: NCT05453877
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-12
• Study Start: 2022-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31
• Primary Completion: 2025-08-01
• Study Completion: 2030-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
subjects from Kailuan community	No intervention will be applied.	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).

Primary Outcome Measures

Name	Time	Method
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
White matter microstructural integrity 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
Lacunes of the brain measured by MRI (magnetic resonance imaging)	every two years up to 30 years

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Kailuan General Hospital; 🇨🇳 Tangshan, Hebei, China