Cerebral Small Vessel DiseasesNCT05985213
Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
An observational study of Cerebral Small Vessel Diseases, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- data collection and follow-up
- How many people
- 1,078 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with CSVD
Who may be able to join
- 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.
Who cannot join
- 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).
- Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.
- Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests.
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- Women who are pregnant or breastfeeding.
- MRI scan contraindicated due to various reasons (such as claustrophobia).
- Any other reasons that prevent the collection of clinical data required for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai
Jia Zhou, pdzhoujia@163.com
About this study
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.
Read the detailed description
Research Objectives:
- 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.
- To explore and summarize the clinical and radiological characteristics of the CSVD population, and identify new risk factors for CSVD.
- To investigate in depth the underlying mechanisms and the relationship between clinical and radiological outcomes in CSVD.
- To establish a multifactor prediction model for cognitive and emotional disorders in CSVD.
- Conditions
- Cerebral Small Vessel Diseases
- Being tested
- data collection and follow-up
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collection and follow-upOther
Main measures and data collection methods:
- Recording of baseline demographic and clinical information of the participants.
- Multimodal magnetic resonance imaging
- blood pressure variability.
- neuropsychological testing
- Blood samples collection
| Study group | Role | What they receive |
|---|---|---|
| CSVD patients | The neuroimaging diagnosis will follow the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria established by the neuroimaging experts in 2013. The interpretation and assessment will be conducted jointly by one experienced radiologist and one experienced neurologist. Receives: Other: data collection and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive state
The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.
Measured: 2020-12-1 to 2027-12-31
Secondary outcomes (2)
Blood pressure variability
24-hour ambulatory blood pressure
Measured: 2020-12-1 to 2027-12-31
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.
Measured: 2020-12-1 to 2027-12-31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Dec 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,078 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985213
- Sponsor's protocol ID
- 2023-128
- Status last verified
- Aug 2023
- First submitted
- 25 May 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT05985213
- Acronym / sponsor ID
- 2023-128
- Conditions
- Cerebral Small Vessel Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,078 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Objectives:
- 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.
- To explore and summarize the clinical and radiological characteristics of the CSVD population, and identify new risk factors for CSVD.
- To investigate in depth the underlying mechanisms and the relationship between clinical and radiological outcomes in CSVD.
- To establish a multifactor prediction model for cognitive and emotional disorders in CSVD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSVD patients | – | Other: data collection and follow-upThe neuroimaging diagnosis will follow the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria established by the neuroimaging experts in 2013. The interpretation and assessment will be conducted jointly by one experienced radiologist and one experienced neurologist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CSVD
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
- Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| data collection and follow-upMain 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 | Other | CSVD patients |
Primary outcome
Cognitive state
Time frame: 2020-12-1 to 2027-12-31
The cognitive function assessment based on Montreal Cognitive Assessment(MoCA) scale.
2 secondary outcomes
Blood pressure variability
Time frame: 2020-12-1 to 2027-12-31
The development of white matter hyperintensities, microbleeds, lacunes and, perivascular spaces.
Time frame: 2020-12-1 to 2027-12-31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jia Zhou principal investigator
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yajing Huo (+86 188 1821 1605, heej07@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive state (time frame: 2020-12-1 to 2027-12-31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.