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

Recruiting now

Conditions studied: Intracranial Artery Stenosis

In brief

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).

Key facts

Study ID

NCT07085299

Run by

Nanjing First Hospital, Nanjing Medical University

People needed

500

Starts

2025-06-01

Expected to finish

2028-12-31

Last updated by the study team

2025-07-25

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 30-80 years.
• Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
• Local residency ≥6 consecutive months.
• Signed informed consent.

You may not qualify if…

• 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.

Where it is running

• Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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