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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200377
Other study ID # ChinaPLAGH-Radiology
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2025

Study information

Verified date July 2022
Source Chinese PLA General Hospital
Contact Kun Cheng, M.S.
Phone +8619921784434
Email dr_chengkun@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Magnetic resonance imaging
Patients recruited will receive Magnetic resonance imaging.

Locations

Country Name City State
China Chinese PLA General Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Progression in total cerebral small vessel disease burden Total cSVD burden assessed by MRI 1 year
Secondary Progression in congnitive impairments Global Z-score by cognitive domain 1 years
Secondary Recurrent ischemic events Recurrent ischemic stroke, TIA and vascular death 1 year
Secondary 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. 90 days and 1 year after qualifying event
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