PRospective Observation on CErebral microvaScular Structure and Function
NCT Number: NCT06579677
Acronym: PROCESS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cerebral Microvascular Dysfunction|Cerebral Small Vessel Diseases|Cognitive Dysfunction|Cerebrovascular Disorders|Cardiovascular Diseases|Population
Interventions: OTHER: Without any intervention
Sponsor: Beijing Tiantan Hospital
Collaborators: People's Hospital of Beijing Daxing District
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 3500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2032-09
Locations: Beijing Tiantan Hospital, Beijing, Beijing, 100070, China

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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, All causes of death includes cardiovascular death and noncardiovascular death., 2024-09 to 2032-09|Atherosclerotic plaque in retinal arteries., 2024-09 to 2032-09|Atherosclerotic plaque in craniocarotid arteries., 2024-09 to 2032-09|Other vascular events, Other vascular events include peripheral vascular disease, subclavian steal syndrome and systemic thromboembolic events., 2024-09 to 2032-09|Vascular interventions, Vascular interventions such as arterial bypass, balloon dilatation, stent implantation, carotid endarterectomy, mechanical thrombolysis and ischemic amputation. These events will be collected by self-report and confirmed by reviewing their medical records., 2024-09 to 2032-09|Mean blood flow velocity in arteries, Mean blood flow velocities in the distal common carotid artery, internal carotid artery bulb, proximal-distal internal carotid artery, and vertebral artery will be measured by pulsed Doppler ultrasound., 2024-09 to 2032-09