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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453877
• Other study ID #: 202201
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 1, 2030

Study information

• Verified date: October 2022
• Source: Beijing Friendship Hospital
• Contact: Zhenchang Wang
• Phone: +86-13501163497
• Email: cjr.wzhch[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2030
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Brain Diseases
• Hypertension

Intervention

Other:
• No intervention will be applied.
This is an observational study.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Kailuan General Hospital	Tangshan	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	KaiLuan General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulse Wave Velocity, PWV		every two years up to 30 years
Other	Lipoprotein		every two years up to 30 years
Primary	White matter hyperintensity of the brain measured by MRI (magnetic resonance imaging)		every two years up to 30 years
Primary	microbleeds of the brain measured by MRI (magnetic resonance imaging)		every two years up to 30 years
Primary	Lacunes of the brain measured by MRI (magnetic resonance imaging)		every two years up to 30 years
Primary	Cerebral blood flow measured by MRI (magnetic resonance imaging)		every two years up to 30 years
Primary	Brain volume measured by MRI (magnetic resonance imaging)		every two years up to 30 years
Primary	White matter microstructural integrity of the brain measured by MRI (magnetic resonance imaging)		every two years up to 30 years
Secondary	blood glucose level		every two years up to 30 years
Secondary	Cervical vascular ultrasound		every two years up to 30 years
Secondary	Fundus color photography of the eyes		every two years up to 30 years
Secondary	Fundus optical coherence tomography (OCT)		every two years up to 30 years
Secondary	Blood pressure (both Systolic and Diastolic Blood Pressure)		every two years up to 30 years
Secondary	BMI (body mass index)		every two years up to 30 years
Secondary	Uric acid		every two years up to 30 years