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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196398
• Other study ID #: XWFFR-3
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Jichang Luo
• Phone: +8613120136577
• Email: luojichang_dr[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Stroke, Ischemic

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	National Key Research and Development Project, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of ischemic stroke or death related to the qualifying artery territory		1 year
Secondary	Functional evaluation	Modified Rankin Scale score	1 year