NCT05985213 Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
| NCT ID | NCT05985213 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Yueyang Integrated Medicine Hospital |
| Condition | Cerebral Small Vessel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,078 participants |
| Start Date | 2020-12-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,078 participants in total. It began in 2020-12-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Participants aged between 18 and 80 years, with no restriction on gender. 2. 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. 3. 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. 4. Participants who are able to understand and agree to participate in the study, and have signed the informed consent form. Exclusion Criteria: 1. 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). 2. Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%. 3. Imaging data reveals intracranial space-occupying lesions. 4. 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). 5. Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding. 6. Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests. 7. Women who are pregnant or breastfeeding. 8. MRI scan contraindicated due to various reasons (such as claustrophobia). 9. Any other reasons that prevent the collection of clinical data required for this study.
Contact & Investigator
Jia Zhou
PRINCIPAL INVESTIGATOR
Shanghai University of Traditional Chinese Medicine
Frequently Asked Questions
Who can join the NCT05985213 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cerebral Small Vessel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05985213 currently recruiting?
Yes, NCT05985213 is actively recruiting participants. Contact the research team at heej07@126.com for enrollment information.
Where is the NCT05985213 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05985213 clinical trial?
NCT05985213 is sponsored by Shanghai Yueyang Integrated Medicine Hospital. The principal investigator is Jia Zhou at Shanghai University of Traditional Chinese Medicine. The trial plans to enroll 1,078 participants.