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

Recruitingn/aAges 30 Years - 80 YearsAllNanjing First Hospital, Nanjing Medical University
NCT07085299 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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 diabetes. 13. Severe cardiac/hepatic/renal dysfunction, hematologic disorders, malignancy, or life expectancy \<1 year. 14. MRI contraindications. 15. History of depression/anxiety/cognitive impairment requiring therapy. 16. Antibiotic/probiotic/glucocorticoid/immunosuppressant use within 1 month pre-enrollment. 17. Current/planned participation in other trials. 18. Inability to cooperate due to psychiatric/emotional disorders. 19. Other investigator-deemed ineligibility.
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What it tests

  • Not listed
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Where

1 site
Nanjing First Hospital, Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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