Magnetic Resonance Imaging in Cerebral Small Vessel Disease

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05200377
Collaborator
(none)
300
1
48
6.3

Study Details

Study Description

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 Phase
  • 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.

Study Design

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

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Progression in total cerebral small vessel disease burden [1 year]

    Total cSVD burden assessed by MRI

Secondary Outcome Measures

  1. Progression in congnitive impairments [1 years]

    Global Z-score by cognitive domain

  2. Recurrent ischemic events [1 year]

    Recurrent ischemic stroke, TIA and vascular death

  3. Modified Rankin Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital Beijing China 100853

Sponsors and Collaborators

  • Chinese PLA General Hospital

Investigators

  • Principal Investigator: Xin Lou, MD, PhD, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xin Lou, Department of Radiology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT05200377
Other Study ID Numbers:
  • ChinaPLAGH-Radiology
First Posted:
Jan 20, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xin Lou, Department of Radiology, Chinese PLA General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022