Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

NCT05677607 | Recruiting DMC

• 1 other identifier: 301Brainmax
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ICAS - Intracranial Atherosclerosis; Cerebral Small Vessel Diseases

Keywords

Intracranial atherosclerosis; Cerebral small vessel disease; Feedback mechanism; Multimodal MRI

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Frequency of stroke of asymptomatic participants

  1-3 YEARS

Study Arms (1)

Intracranial atherosclerosis and small vessel disease

Patients diagnosed with intracranial large artery atherosclerosis and cerebral small vessel disease based on imaging screening.

Diagnostic Test: Magnetic resonance imaging

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

Imaging diagnostics mainly based on Magnetic resonance imaging.

Intracranial atherosclerosis and small vessel disease

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with at least on intracranial artery ≥ 50% atherosclerotic stenosis.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Cerebral Small Vessel Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jinhao Lyu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinhao Lyu

CONTACT

+8615903562929; 330322990@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)