PRospective Observation on CErebral microvaScular Structure and Function

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-75
SponsorBeijing Tiantan Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Without any intervention

    Other intervention

    No interventions will be performed.

Treatment groups

3,500 Participants
are divided into 1 treatment group
Group A: PROCESS Cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2024-09 to 2032-09
2

Neurovascular coupling

Neurovascular coupling is one of cerebral small vessel function indicators and will be measured by 3.0 T MRI.

Time frame
2024-09 to 2032-09
3

Cerebral perfusion

Cerebral perfusion is one of cerebral small vessel function indicators and will be measured by 3.0 T MRI.

Time frame
2024-09 to 2032-09
4

Cerebral autoregulation

Cerebral autoregulation is one of cerebral small vessel function indicators and will be measured by transcranial Doppler ultrasonography.

Time frame
2024-09 to 2032-09

Secondary outcomes

1

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.

Time frame
2024-09 to 2032-09
2

Cognitive impairment measured by the Montreal Cognitive Assessment (MoCA) scale

Time frame
2024-09 to 2032-09
3

Cognitive impairment measured by the Mini-Mental State Examination (MMSE) scale

Time frame
2024-09 to 2032-09
4

All causes of death

All causes of death includes cardiovascular death and noncardiovascular death.

Time frame
2024-09 to 2032-09

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Beijing Daxing District People Hospital

Collaborator