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Recruiting NCT07085299

Gut Microbiota and Prognostic Outcomes in Intracranial Arterial Stenosis Patients(GROW-ICAS)

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Trial Parameters

Condition Intracranial Artery Stenosis
Sponsor Nanjing First Hospital, Nanjing Medical University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 30 Years
Max Age 80 Years
Start Date 2025-06-01
Completion 2028-12-31

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Brief Summary

GROW-ICAS (Gut microBiota and prOgnostic Outcomes in IntraCranial Arterial Stenosis) is a prospective observational cohort study that enrolls patients with intracranial arterial stenosis to investigate the correlations between their gut microbiota, metabolomic, and transcriptomic profiles and three key clinical domains: functional outcomes, vascular plaque imaging characteristics, and post-stroke non-motor dysfunctions (including cognitive impairment, depression, anxiety, and fatigue).

Eligibility Criteria

Inclusion Criteria: 1. Age 30-80 years. 2. Intracranial arterial stenosis confirmed by CTA/MRA/DSA. 3. Local residency ≥6 consecutive months. 4. Signed informed consent. Exclusion Criteria: 1. Tandem extracranial stenosis (≥50%) proximal to the target intracranial stenotic vessel. 2. Non-atherosclerotic intracranial stenosis. 3. Extracranial/intracranial endovascular treatment within 30 days pre-enrollment or planned intervention within 6 months. 4. Intracranial hemorrhage within 90 days pre-enrollment. 5. Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation. 6. Cardioembolic embolism. 7. Active bleeding/hemorrhagic diathesis. 8. Major surgery within 30 days pre-enrollment or planned within 6 months post-enrollment. 9. Severe neurological deficits impairing independent living or dementia/psychiatric disorders hindering follow-up. 10. Pregnancy/lactation/planned pregnancy. 11. Chronic inflammatory/autoimmune diseases. 12. Uncontrolled hypertension or diabete

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