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Magnetic Resonance Imaging in Cerebral Small Vessel Disease

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ClinicalTrials.gov Identifier: NCT05200377
Recruitment Status : Recruiting
First Posted : January 20, 2022
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Xin Lou, Chinese PLA General Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Cerebral Small Vessel Diseases MRI Diagnostic Test: Magnetic resonance imaging

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging in Cerebral Small Vessel Disease
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Diagnostic Test: Magnetic resonance imaging
Patients recruited will receive Magnetic resonance imaging.




Primary Outcome Measures :
  1. Progression in total cerebral small vessel disease burden [ Time Frame: 1 year ]
    Total cSVD burden assessed by MRI


Secondary Outcome Measures :
  1. Progression in congnitive impairments [ Time Frame: 1 years ]
    Global Z-score by cognitive domain

  2. Recurrent ischemic events [ Time Frame: 1 year ]
    Recurrent ischemic stroke, TIA and vascular death

  3. Modified Rankin Scale [ Time Frame: 90 days and 1 year after qualifying event ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with clinically or radiologically evidenced cerebral small vessel disease.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindications to MRI
  • Standard MRI of bad quality due to movement artefacts
  • Pregnant
  • Unable to tolerate MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05200377


Contacts
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Contact: Kun Cheng, M.S. +8619921784434 dr_chengkun@163.com

Locations
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China
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Kun Cheng, M.S.    +86 19921784434    dr_chengkun@163.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Xin Lou, MD, PhD Chinese PLA General Hospital
Publications:
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Responsible Party: Xin Lou, Department of Radiology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT05200377    
Other Study ID Numbers: ChinaPLAGH-Radiology
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xin Lou, Chinese PLA General Hospital:
Cerebral small vessel diseases
Cognitive impairments
Lesion burden
MRI
Additional relevant MeSH terms:
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Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases