PRospective Observation on CErebral microvaScular Structure and Function
PROCESS
1 other identifier
observational
3,500
1 country
2
Brief Summary
This is a population-based prospective cohort study, aiming to assess the prevalence, distributional characteristics, and dynamic change of cerebral small vessel dysfunction in a Chinese community population using advanced vascular imaging techniques; meanwhile to investigate the effect of vascular risk factors on cerebral small vessel dysfunction, cardiovascular and cerebrovascular diseases, cognitive dysfunction, and mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedStudy Start
First participant enrolled
October 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2032
January 6, 2025
January 1, 2025
7.4 years
August 23, 2024
January 2, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Cerebral small vessel disease
Cerebral small vessel disease will be evaluated using 3.0 T MRI based on imaging markers of asymptomatic cerebral infarction, cerebral microbleeds, lacunar, white matter hyperintensity, enlarged perivascular space, and cerebral atrophy.
2024-09 to 2032-09
Neurovascular coupling
Neurovascular coupling is one of cerebral small vessel function indicators and will be measured by 3.0 T MRI.
2024-09 to 2032-09
Cerebral perfusion
Cerebral perfusion is one of cerebral small vessel function indicators and will be measured by 3.0 T MRI.
2024-09 to 2032-09
Cerebral autoregulation
Cerebral autoregulation is one of cerebral small vessel function indicators and will be measured by transcranial Doppler ultrasonography.
2024-09 to 2032-09
Cerebral resting blood flow
Cerebral resting blood flow is one of cerebral small vessel function indicators and will be measured by transcranial Doppler ultrasonography.
2024-09 to 2032-09
Secondary Outcomes (9)
Composite vascular events
2024-09 to 2032-09
Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA) scale
2024-09 to 2032-09
Cognitive impairment measured by the Mini-Mental State Examination (MMSE) scale
2024-09 to 2032-09
All causes of death
2024-09 to 2032-09
Atherosclerotic plaque in retinal arteries.
2024-09 to 2032-09
- +4 more secondary outcomes
Study Arms (1)
PROCESS Cohort
Interventions
Eligibility Criteria
The target population of the PROCESS study is community-dwelling adults aged 50-75 years based on cluster sampling from villages and communities of Daxing District, Beijing. The steering committee will attempt to ensure population representativeness of the sample. These selected villages and communities will be living communities (not occupational communities) with little population migration.
You may qualify if:
- Community-dwelling adults aged 50-75 years;
- Registered Beijing household residents or residents who can be followed up stably in their own communities for a long period;
- Subjects with written informed consents.
You may not qualify if:
- Residents with moderate to severe disabilities (MRS ≥3), mental illness, stroke, dementia, and other serious neurological disorders (e.g., encephalitis, Parkinson's disease, epilepsy, brain tumors, and rare genetic diseases of the nervous system);
- Life expectancy of ≤4 years due to serious diseases such as end-stage cancer;
- Contraindications to magnetic resonance imaging such as implanted devices (e.g., pacemakers, defibrillators, and others);
- Residents who are participating in other studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Tiantan Hospitallead
- Beijing Daxing District People Hospitalcollaborator
Study Sites (2)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070, China
Beijing Daxing District People Hospital
Beijing, Beijing Municipality, 102600, China
Biospecimen
The samples of fasting blood, morning urine, feces, oral plaque bacteria will be collected at baseline to test genetic and metabolomic markers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yilong Wang, MD, PhD
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 30, 2024
Study Start
October 18, 2024
Primary Completion (Estimated)
March 1, 2032
Study Completion (Estimated)
October 1, 2032
Last Updated
January 6, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
The data can be requested through the website of the data management system (http://paper.ncrcnd.org.cn/) or by sending email to the principal investigators.