Intracranial Artery Stenosis
Conditions
Keywords
intracranial artery stenosis, Gut Microbiota
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).
Interventions
None listed
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD). | From enrollment to 1 year | The HAMD total score serves as a reliable indicator of symptom severity, where lower scores correspond to milder symptoms and higher scores indicate greater symptom severity. |
| Functional outcomes were assessed using the modified Rankin Scale (mRS). | From enrollment to 1 year | Functional outcomes were assessed using the modified Rankin Scale (mRS), a 7-point scale ranging from 0 to 6, with higher scores indicating greater disability. |
| Anxiety severity was assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA). | From enrollment to 1 year | The Hamilton Anxiety Rating Scale (HAMA-14) was administered to quantify anxiety severity. A direct correlation exists between total scores and clinical symptom burden, with elevated scores denoting increased severity. |
| Cognitive function was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). | From enrollment to 1 year | Both scales have a maximum score of 30 points, with lower scores indicating greater cognitive impairment. |
| Fatigue severity was assessed using the 9-item Fatigue Severity Scale (FSS). | From enrollment to 1 year | The FSS is a valid and reliable 7-point Likert scale used for assessing and quantifying fatigue, with scores ranging from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates more severe fatigue. |
Countries
China
Contacts
Primary ContactJunshan Zhou
Backup ContactMengmeng Gu
Outcome results
None listed