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

Recruiting

• Conditions: Intracranial Artery Stenosis

• Registration Number: NCT07085299
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Changes in Imaging Characteristics of Intracranial Vascular Plaques.	From enrollment to 1 year	* Plaque Burden = Σ (Cross-sectional wall area - Cross-sectional lumen area) / Σ Cross-sectional wall area × 100%; * Change in Plaque Burden = Plaque burden at Week 24/48 - Baseline plaque burden

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China