Magnetic Resonance Imaging in Cerebral Small Vessel Disease

MRI Clinical Trial

Official title:

Magnetic Resonance Imaging in Cerebral Small Vessel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200377
• Other study ID #: ChinaPLAGH-Radiology
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• MRI

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