Image

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

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

Recruiting
18-80 years
All
Phase N/A

Powered by AI

Overview

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.

Description

Research Objectives:

  1. To conduct a longitudinal study on patients with cerebral small vessel disease (CSVD) and observe the dynamic evolution of their cognitive functioning, emotional disorders, and other related factors.
  2. To explore and summarize the clinical and radiological characteristics of the CSVD population, and identify new risk factors for CSVD.
  3. To investigate in depth the underlying mechanisms and the relationship between clinical and radiological outcomes in CSVD.
  4. To establish a multifactor prediction model for cognitive and emotional disorders in CSVD.

Eligibility

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.

Study details
    Cerebral Small Vessel Diseases

NCT05985213

Shanghai Yueyang Integrated Medicine Hospital

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.