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

Effects of Medical Treatment of Intracranial Atherosclerotic Diseases Based on Magnetic Resonance Fractional Flow Reserve

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Jichang Luo; Phone Number: +8613120136577; Email: luojichang_dr@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Xuanwu Hospital, Capital Medical University
      • Contact: Jichang Luo; Email: luojichang_dr@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic, moderate to severe stenosis of major arteries in intracranial anterior circulation. The stenosis degree is ≥ 50%, confirmed by imaging evidence, according to modified WASID criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Decompensated blood flow reserve; ICAS patients with decompensated cerebral blood flow reserve diagnosed by MR-FFR (FFR baseline≥0.81).	Drug: Standard Medical Treatment on the basis of anti-platelet therapy; Anti-platelet therapy: aspirin 75mg+clopidogrel 100mg will be applied for patients with severe ICAS stenosis (70%-90%) suffering stroke or TIA within 30 days. After 90 days, single anti-platelet therapy will be continued.; Intensive statin therapy: Statins with high doses; Blood pressure: below 140/90mmHg; LDL: less than 1.81mmol/L(70mg/dl); Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%; Cigarette and alcohol quitting; Oral anticoagulants for atrial fibrillation
Normal blood flow reserve; ICAS patients with normal cerebral blood flow reserve determined by MR-FFR (FFR baseline<0.81).	Drug: Standard Medical Treatment on the basis of anti-platelet therapy; Anti-platelet therapy: aspirin 75mg+clopidogrel 100mg will be applied for patients with severe ICAS stenosis (70%-90%) suffering stroke or TIA within 30 days. After 90 days, single anti-platelet therapy will be continued.; Intensive statin therapy: Statins with high doses; Blood pressure: below 140/90mmHg; LDL: less than 1.81mmol/L(70mg/dl); Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%; Cigarette and alcohol quitting; Oral anticoagulants for atrial fibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The composite of ischemic stroke or death related to the qualifying artery territory	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional evaluation	Modified Rankin Scale score	1 year

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: National Key Research and Development Project, China

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: December 25, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Hemodynamics; Fractional Flow Reserve; Intracranial atherosclerotic diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Stroke; Intracranial Arterial Diseases; Ischemic Stroke; Atherosclerosis; Intracranial Arteriosclerosis
• Other Study ID Numbers: XWFFR-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No