Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Yueyang Integrated Medicine Hospital

About this trial

This cohort study involves the dynamic collection of clinical information, including serum parameters , blood pressure variability, imaging data, and neuropsychological scales, in patients with cerebral small vessel disease (CSVD). The study aims to summarise the clinical and imaging characteristics of the CSVD population and identify novel CSVD risk factors. Additionally, this study intend to uncover the mechanisms underlying the clinical and imaging outcomes of CSVD. Furthermore, a multivariable prediction model for cognitive and mood disorders in patients with CSVD will be established.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants aged between 18 and 80 years, with no restriction on gender.

Participants who have completed a 3.0T MRI of the head within one year at Yueyang Hospital, and meet the imaging diagnostic criteria of the 2013 STRIVE guidelines.

Participants who have a Modified Rankin Scale (mRS) score of 0-2 (able to perform activities of daily living) at the time of the visit.

Participants who are able to understand and agree to participate in the study, and have signed the informed consent form.

Disqualifiers

Diagnosis of symptomatic lacunar syndrome without 6 months of onset (participants can be enrolled after 6 months to avoid the impact of the acute phase).

Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%.

Imaging data reveals intracranial space-occupying lesions.

A history of other neurological or mental illnesses with a definite diagnosis of the cause, including stroke (excluding lacunar infarctions), neurodegenerative diseases (such as Parkinson's disease and Alzheimer's disease).

Trial population

Patients with CSVD

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • data collection and follow-up

    Other intervention

    Main measures and data collection methods: 1. Recording of baseline demographic and clinical information of the participants. 2. Multimodal magnetic resonance imaging 3. blood pressure variability. 4. neuropsychological testing 5. Blood samples collection

Treatment groups

1,078 Participants
are divided into 1 treatment group
Group A: CSVD patients1 intervention

Trial outcomes

Primary outcomes

1

Cognitive state

The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.

Time frame
2020-12-1 to 2027-12-31

Secondary outcomes

1

Blood pressure variability

24-hour ambulatory blood pressure

Time frame
2020-12-1 to 2027-12-31
2

The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.

If the fine structures are not clearly visible on the 3.0T MRI and further evaluation is needed for the clinical and therapeutic assessment of cerebral small vessel disease, the patient will be referred to undergo a 7.0T MRI examination.

Time frame
2020-12-1 to 2027-12-31

Other outcomes

Sponsors and contacts

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