Clinical trial NCT05453877: Clinical Indicators and Brain Image Data: a Study Based on Kailuan Cohort
Official title: Clinical Indicators and Brain Image Data: a Cohort Study Based on Kailuan Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Diseases
Hypertension
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: KaiLuan General Hospital
First posted: 2022-07-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects from Kailuan Cohorts

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.


Eligibility criteria: 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).

Primary outcomes:
measure: White matter hyperintensity of the brain measured by MRI (magnetic resonance imaging)
timeFrame: every two years up to 30 years
measure: microbleeds of the brain measured by MRI (magnetic resonance imaging)
timeFrame: every two years up to 30 years
measure: Lacunes of the brain measured by MRI (magnetic resonance imaging)
timeFrame: every two years up to 30 years
measure: Cerebral blood flow measured by MRI (magnetic resonance imaging)
timeFrame: every two years up to 30 years
measure: Brain volume measured by MRI (magnetic resonance imaging)
timeFrame: every two years up to 30 years
measure: White matter microstructural integrity of the brain measured by MRI (magnetic resonance imaging)
timeFrame: every two years up to 30 years
Secondary outcomes:
measure: blood glucose level
timeFrame: every two years up to 30 years
measure: Cervical vascular ultrasound
timeFrame: every two years up to 30 years
measure: Fundus color photography of the eyes
timeFrame: every two years up to 30 years
measure: Fundus optical coherence tomography (OCT)
timeFrame: every two years up to 30 years
measure: Blood pressure (both Systolic and Diastolic Blood Pressure)
timeFrame: every two years up to 30 years
measure: BMI (body mass index)
timeFrame: every two years up to 30 years
measure: Uric acid
timeFrame: every two years up to 30 years
Other outcomes:
measure: Pulse Wave Velocity, PWV
timeFrame: every two years up to 30 years
measure: Lipoprotein
timeFrame: every two years up to 30 years
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Tangshan
country: China
facility: Kailuan General Hospital
state: Hebei
Study officials:
References: