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

NCT ID: NCT06196398

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Stroke, Ischemic Intracranial Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Decompensated blood flow reserve

ICAS patients with decompensated cerebral blood flow reserve diagnosed by MR-FFR (FFR baseline≥0.81).

Standard Medical Treatment on the basis of anti-platelet therapy

Intervention Type DRUG

1. 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.
2. Intensive statin therapy: Statins with high doses
3. Blood pressure: below 140/90mmHg
4. LDL: less than 1.81mmol/L(70mg/dl)
5. Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%
6. Cigarette and alcohol quitting
7. 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).

Standard Medical Treatment on the basis of anti-platelet therapy

Intervention Type DRUG

1. 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.
2. Intensive statin therapy: Statins with high doses
3. Blood pressure: below 140/90mmHg
4. LDL: less than 1.81mmol/L(70mg/dl)
5. Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%
6. Cigarette and alcohol quitting
7. Oral anticoagulants for atrial fibrillation

Interventions

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Standard Medical Treatment on the basis of anti-platelet therapy

1. 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.
2. Intensive statin therapy: Statins with high doses
3. Blood pressure: below 140/90mmHg
4. LDL: less than 1.81mmol/L(70mg/dl)
5. Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7%
6. Cigarette and alcohol quitting
7. Oral anticoagulants for atrial fibrillation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Key Research and Development Project, China

UNKNOWN

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jichang Luo

Role: CONTACT

+8613120136577

Facility Contacts

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Jichang Luo

Role: primary

Other Identifiers

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XWFFR-3

Identifier Type: -

Identifier Source: org_study_id

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