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

Clinical Indicators and Brain Image Data: a Cohort 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.

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases; Hypertension
• Intervention / Treatment: Other: No intervention will be applied.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Jing Li; Phone Number: +86-13693544716; Email: lijingxbhtr@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Not yet recruiting
      • Beijing Friendship Hospital, Capital Medical University
  • Hebei
    • Tangshan, Hebei, China, 063000
      • Recruiting
      • Kailuan General Hospital
      • Contact: Ying Hui; Phone Number: +86-15373588526; Email: wyt0086@163.com
      • Principal Investigator: Shouling Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects from Kailuan Cohorts

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
blood glucose level	every two years up to 30 years
Cervical vascular ultrasound	every two years up to 30 years
Fundus color photography of the eyes	every two years up to 30 years
Fundus optical coherence tomography (OCT)	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
Uric acid	every two years up to 30 years

Other Outcome Measures

Outcome Measure	Time Frame
Pulse Wave Velocity, PWV	every two years up to 30 years
Lipoprotein	every two years up to 30 years

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: KaiLuan General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2025
• Study Completion (ANTICIPATED): August 1, 2030

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (ACTUAL): July 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: 202201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No