NCT06196398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

December 25, 2023

Last Update Submit

December 25, 2023

Conditions

Stroke, IschemicIntracranial Atherosclerosis

Keywords

Intracranial atherosclerotic diseasesFractional Flow ReserveHemodynamicsStroke

Outcome Measures

Primary Outcomes (1)

  • The composite of ischemic stroke or death related to the qualifying artery territory

    1 year

Secondary Outcomes (1)

  • Functional evaluation

    1 year

Study Arms (2)

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

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

Interventions

Standard Medical Treatment on the basis of anti-platelet therapyDRUG

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

Decompensated blood flow reserveNormal blood flow reserve

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeIntracranial ArteriosclerosisStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial Arterial DiseasesArteriosclerosisArterial Occlusive Diseases

Central Study Contacts

Jichang Luo

CONTACT

+8613120136577luojichang_dr@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 9, 2024

Study Start

January 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 9, 2024

Record last verified: 2023-12

Locations

CN(1)