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

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

Recruiting
30-80 years
All
Phase N/A

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Overview

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

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.

Study details
    Intracranial Artery Stenosis

NCT07085299

Nanjing First Hospital, Nanjing Medical University

15 October 2025

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