Gut Microbiota and Prognostic Outcomes in Intracranial Arterial Stenosis Patients（GROW-ICAS）
Correlation Study Between Gut Microbiota and Prognosis in Patients With Intracranial Arterial Stenosis（GROW-ICAS）
Nanjing First Hospital, Nanjing Medical University
500 participants
Jun 1, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- Age 30-80 years.
- Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
- Local residency ≥6 consecutive months.
- Signed informed consent.
Exclusion Criteria19
- Tandem extracranial stenosis (≥50%) proximal to the target intracranial stenotic vessel.
- Non-atherosclerotic intracranial stenosis.
- Extracranial/intracranial endovascular treatment within 30 days pre-enrollment or planned intervention within 6 months.
- Intracranial hemorrhage within 90 days pre-enrollment.
- Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
- Cardioembolic embolism.
- Active bleeding/hemorrhagic diathesis.
- Major surgery within 30 days pre-enrollment or planned within 6 months post-enrollment.
- Severe neurological deficits impairing independent living or dementia/psychiatric disorders hindering follow-up.
- Pregnancy/lactation/planned pregnancy.
- Chronic inflammatory/autoimmune diseases.
- Uncontrolled hypertension or diabetes.
- Severe cardiac/hepatic/renal dysfunction, hematologic disorders, malignancy, or life expectancy \<1 year.
- MRI contraindications.
- History of depression/anxiety/cognitive impairment requiring therapy.
- Antibiotic/probiotic/glucocorticoid/immunosuppressant use within 1 month pre-enrollment.
- Current/planned participation in other trials.
- Inability to cooperate due to psychiatric/emotional disorders.
- Other investigator-deemed ineligibility.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07085299