Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

Cerebral Small Vessel Diseases Clinical Trial

Official title:

Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677607
• Other study ID #: 301Brainmax
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2023
• Source: Chinese PLA General Hospital
• Contact: Jinhao Lyu
• Phone: +8615903562929
• Email: 330322990[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.

Description:

Cerebrovascular disease is the most common cause of death worldwide. There is a close link in structure and function between the intracranial large arteries and cerebral small vessels. Moreover, growing evidences have demonstrated that large artery atherosclerosis often coexists with small vessel disease, which may deteriorate the clinical outcomes of stroke and dementia. The mutual feedback mechanism between them is not fully understood. The present study focuses on the mechanism of mutual feedback between large artery atherosclerosis and cerebral small vessel disease by using magnetic resonance imaging. The study may provide biomarkers for the early prevention and treatment of cerebrovascular disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• At least one intracranial artery = 50% atherosclerotic stenosis
• Modified Rankin Scale < 2
• Mini-mental State Examination > 24

Exclusion Criteria:

• Concurrent ipsilateral extracranial artery = 50% stenosis
• Pregnant women
• Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)

Related Conditions & MeSH terms

• Atherosclerosis
• Cerebral Small Vessel Diseases
• Intracranial Arteriosclerosis

Intervention

Diagnostic Test:
• Magnetic resonance imaging
Imaging diagnostics mainly based on Magnetic resonance imaging.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression in total cerebral small vessel disease burden	Total cerebral small vessel disease burden is assessed according to a sum of scores of white matter hyperintensity, cerebral microbleeds, lacunes and enlarged perivasular spaces on magnetic resonance imaging sequences.	1-3 YEARS
Primary	Frequency of stroke recurrence	The percentage of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the targeted stenotic vessel.	1-3 YEARS
Secondary	Frequency of stroke of asymptomatic participants	The percentage of asymptomatic participants who suffer from stroke after enrollment in the territory of the targeted stenotic vessel.	1-3 YEARS