Cerebral Small Vessel DiseasesNCT05200377
Magnetic Resonance Imaging in Cerebral Small Vessel Disease
An observational study of Cerebral Small Vessel Diseases and MRI, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Diseases, MRI
- What is being tested?
- Magnetic resonance imaging
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with clinically or radiologically evidenced cerebral small vessel disease.
Who may be able to join
- Clinical evidence of cerebral small vessel disease or MRI evidence of lacunar infarcts and white matter hyperintensity
- No disability (modified Rankin's scale < 2)
- No dementia (MMSE > 24 and absence of dependence in daily activities)
- Able and willing to consent
Who cannot join
- Contraindications to MRI
- Standard MRI of bad quality due to movement artefacts
- Pregnant
- Unable to tolerate MRI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Kun Cheng, M.S., +86 19921784434, dr_chengkun@163.com
About this study
Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.
Read the detailed description
Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) is sensitive to change in white matter structure and subtle vascular function alternation which correlates with cognition impairments in cSVD. MRI manifestation may also represent as useful surrogate marker. Development of advanced MRI technologies promotes their invaluable application in brain and vascular qualitative and quantitative assessment. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.
- Conditions
- Cerebral Small Vessel Diseases, MRI
- Being tested
- Magnetic resonance imaging
- Keywords
- Cerebral small vessel diseases, Cognitive impairments, Lesion burden, MRI
- Medical subject headings
- Cerebral Small Vessel Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Patients recruited will receive Magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral small vessel disease group | Patients with clinically and radiologically evidenced cerebral small vessel disease. Patients are grouped by severity of cerebral small vessel disease assessed by comprehensive MRI findings. Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression in total cerebral small vessel disease burden
Total cSVD burden assessed by MRI
Measured: 1 year
Secondary outcomes (3)
Progression in congnitive impairments
Global Z-score by cognitive domain
Measured: 1 years
Recurrent ischemic events
Recurrent ischemic stroke, TIA and vascular death
Measured: 1 year
Modified Rankin Scale
Disability assessed by modified Rankin Scale (mRS). The scores, ranging from 0 (no symptoms) to 6 (death), were recorded by phone call or outpatient consultation. A favorable outcome was defined as mRS score 0-2, unfavorable outcome was defined as mRS score > 2.
Measured: 90 days and 1 year after qualifying event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, MD, PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200377
- Sponsor's protocol ID
- ChinaPLAGH-Radiology
- Status last verified
- Jul 2022
- First submitted
- 6 Jan 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wardlaw JM, Smith C, Dichgans M. Small vessel disease: mechanisms and clinical implications. Lancet Neurol. 2019 Jul;18(7):684-696. doi: 10.1016/S1474-4422(19)30079-1. Epub 2019 May 13.
PubMed 31097385Duan C, Bian X, Cheng K, Lyu J, Xiong Y, Xiao S, Wang X, Duan Q, Li C, Huang J, Hu J, Wang ZJ, Zhou X, Lou X. Synthesized 7T MPRAGE From 3T MPRAGE Using Generative Adversarial Network and Validation in Clinical Brain Imaging: A Feasibility Study. J Magn Reson Imaging. 2024 May;59(5):1620-1629. doi: 10.1002/jmri.28944. Epub 2023 Aug 9.
PubMed 37559435
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging in Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT05200377
- Acronym / sponsor ID
- ChinaPLAGH-Radiology
- Conditions
- Cerebral Small Vessel Diseases, MRI
- Keywords
- Cerebral small vessel diseases, Cognitive impairments, Lesion burden, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Jan 2022 (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.
Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.
Detailed description
Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) is sensitive to change in white matter structure and subtle vascular function alternation which correlates with cognition impairments in cSVD. MRI manifestation may also represent as useful surrogate marker. Development of advanced MRI technologies promotes their invaluable application in brain and vascular qualitative and quantitative assessment. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral small vessel disease group | – | Diagnostic Test: Magnetic resonance imagingPatients with clinically and radiologically evidenced cerebral small vessel disease. Patients are grouped by severity of cerebral small vessel disease assessed by comprehensive MRI findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically or radiologically evidenced cerebral small vessel disease.
Key inclusion criteria (4 listed)
- Clinical evidence of cerebral small vessel disease or MRI evidence of lacunar infarcts and white matter hyperintensity
- No disability (modified Rankin's scale < 2)
- No dementia (MMSE > 24 and absence of dependence in daily activities)
- Able and willing to consent
Key exclusion criteria (4 listed)
- Contraindications to MRI
- Standard MRI of bad quality due to movement artefacts
- Pregnant
- Unable to tolerate MRI
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 |
|---|---|---|
| Magnetic resonance imagingPatients recruited will receive Magnetic resonance imaging. | Diagnostic test | Cerebral small vessel disease group |
Primary outcome
Progression in total cerebral small vessel disease burden
Time frame: 1 year
Total cSVD burden assessed by MRI
3 secondary outcomes
Progression in congnitive impairments
Time frame: 1 years
Recurrent ischemic events
Time frame: 1 year
Modified Rankin Scale
Time frame: 90 days and 1 year after qualifying event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 31097385Wardlaw JM, Smith C, Dichgans M. Small vessel disease: mechanisms and clinical implications. Lancet Neurol. 2019 Jul;18(7):684-696. doi: 10.1016/S1474-4422(19)30079-1. Epub 2019 May 13.
- Derived from this study: PubMed 37559435Duan C, Bian X, Cheng K, Lyu J, Xiong Y, Xiao S, Wang X, Duan Q, Li C, Huang J, Hu J, Wang ZJ, Zhou X, Lou X. Synthesized 7T MPRAGE From 3T MPRAGE Using Generative Adversarial Network and Validation in Clinical Brain Imaging: A Feasibility Study. J Magn Reson Imaging. 2024 May;59(5):1620-1629. doi: 10.1002/jmri.28944. Epub 2023 Aug 9.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Xin Lou, MD, PhD principal investigator
Chinese PLA General Hospital
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 and MRI, run by Chinese PLA General 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 4 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Cheng, M.S. (+8619921784434, dr_chengkun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression in total cerebral small vessel disease burden (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05200377, which also lists 2 linked publications.
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 20 Jul 2022.