Effects of Medical Treatment of ICAS With Hemodynamic Disorders Based on MR-FFR

Recruiting

• Conditions: Intracranial Atherosclerosis; Stroke, Ischemic
• Interventions: Drug: Standard Medical Treatment on the basis of anti-platelet therapy

• Registration Number: NCT06196398
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This multicenter prospective cohort study aims to compare the difference in the effects of medical treatment within 1 year between the two groups of ICAS patients divided hemodynamically by Magnetic Resonance Fractional Flow Reserve. PC MRA will be applied for FFR measurement. The primary outcome is the composite of ischemic stroke or death related to the qualifying artery territory for 1 year.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-25
• Study First Submitted QC: 2023-12-25
• Last Update Submitted: 2023-12-25
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation.
2. 50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTA or MRA.
3. mRS 0-2 points
4. Informed of the study protocol and objectives.

Exclusion Criteria

1. Previous endovascular treatment or surgery for cerebrovascular diseases
2. Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI
3. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection.
4. Pregnancy or in the preparation for pregnancy
5. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia
6. Contraindication for antiplatelet drugs or statins
7. Patients with severe dementia or mental disorders, who cannot cooperate with examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal blood flow reserve	Standard Medical Treatment on the basis of anti-platelet therapy	ICAS patients with normal cerebral blood flow reserve determined by MR-FFR (FFR baseline\<0.81).
Decompensated blood flow reserve	Standard Medical Treatment on the basis of anti-platelet therapy	ICAS patients with decompensated cerebral blood flow reserve diagnosed by MR-FFR (FFR baseline≥0.81).

Primary Outcome Measures

Name	Time	Method
The composite of ischemic stroke or death related to the qualifying artery territory	1 year

Secondary Outcome Measures

Name	Time	Method
Functional evaluation	1 year	Modified Rankin Scale score

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China