About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Without any intervention
Other interventionNo interventions will be performed.
Treatment groups
Trial outcomes
Primary outcomes
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.
Neurovascular coupling
Neurovascular coupling is one of cerebral small vessel function indicators and will be measured by 3.0 T MRI.
Cerebral perfusion
Cerebral perfusion is one of cerebral small vessel function indicators and will be measured by 3.0 T MRI.
Cerebral autoregulation
Cerebral autoregulation is one of cerebral small vessel function indicators and will be measured by transcranial Doppler ultrasonography.
Secondary outcomes
Composite vascular events
Composite vascular events include non-fatal acute myocardial infarction, non-fatal acute stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage), hospitalization for vascular reasons (including unstable angina pectoris, transient ischemic attack, and other ischemic vascular events), and vascular deaths (fatal infarcts, fatal strokes, and other vascular deaths). These events will be collected by self-report and confirmed by reviewing their medical records.
Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA) scale
Cognitive impairment measured by the Mini-Mental State Examination (MMSE) scale
All causes of death
All causes of death includes cardiovascular death and noncardiovascular death.
Sponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
Beijing Daxing District People Hospital
Collaborator