NCT05200377

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

4 years

First QC Date

January 6, 2022

Last Update Submit

July 18, 2022

Conditions

Cerebral Small Vessel DiseasesMRI

Keywords

Cerebral small vessel diseasesCognitive impairmentsLesion burdenMRI

Outcome Measures

Primary Outcomes (1)

  • Progression in total cerebral small vessel disease burden

    Total cSVD burden assessed by MRI

    1 year

Secondary Outcomes (3)

  • Progression in congnitive impairments

    1 years

  • Recurrent ischemic events

    1 year

  • Modified Rankin Scale

    90 days and 1 year after qualifying event

Study Arms (1)

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

Interventions

Magnetic resonance imagingDIAGNOSTIC_TEST

Patients recruited will receive Magnetic resonance imaging.

Cerebral small vessel disease group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with clinically or radiologically evidenced cerebral small vessel disease.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31097385BACKGROUND

  • Duan 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.

    PMID: 37559435DERIVED

MeSH Terms

Conditions

Cerebral Small Vessel DiseasesCognitive Dysfunction

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Xin Lou, MD, PhD

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Cheng, M.S.

CONTACT

+8619921784434dr_chengkun@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Radiology

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

CN(1)