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Clinical Trials in China / NCT07085299
Recruiting Observational

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

NCT07085299 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing First Hospital, Nanjing Medical University
Phase
Observational
Started
2025-06-01
Last updated
2025-07-25

Condition(s) studied

Intracranial Artery Stenosis

Study 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

Sex
ALL
Min age
30 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Stroke Recurrence in Patients with Symptomatic Intracranial Arterial Stenosis — From enrollment to 1 year
    Patients with symptomatic intracranial arterial stenosis experiencing recurrent cerebrovascular events, defined as either novel ischemic stroke or transient ischemic attack (TIA).
  • Stroke Occurrence in Patients with Asymptomatic Intracranial Arterial Stenosis — From enrollment to 1 year
    Incident cerebrovascular events-comprising ischemic stroke or transient ischemic attack (TIA)-occurring in patients exhibiting asymptomatic intracranial arterial stenosis.

Trial sites (1)

FacilityCityRegionStatus
Nanjing First Hospital, Nanjing Medical University Nanjing Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07085299 on ClinicalTrials.gov ↗ ← All trials in China