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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).
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| Measure | Description | Time Frame |
|---|---|---|
| Stroke Recurrence in Patients with Symptomatic Intracranial Arterial Stenosis | Patients with symptomatic intracranial arterial stenosis experiencing recurrent cerebrovascular events, defined as either novel ischemic stroke or transient ischemic attack (TIA). | From enrollment to 1 year |
| Stroke Occurrence in Patients with Asymptomatic Intracranial Arterial Stenosis | Incident cerebrovascular events-comprising ischemic stroke or transient ischemic attack (TIA)-occurring in patients exhibiting asymptomatic intracranial arterial stenosis. | From enrollment to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Imaging Characteristics of Intracranial Vascular Plaques. |
| From enrollment to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcomes were assessed using the modified Rankin Scale (mRS). | 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. | From enrollment to 1 year |
| Cognitive function was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). |
Inclusion Criteria:
Exclusion Criteria:
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Patients with intracranial arterial stenosis recruited from the Department of Neurology, Nanjing First Hospital (Affiliated Nanjing Hospital of Nanjing Medical University)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junshan Zhou | Contact | 8602587726218 | zhjsh333@126.com | |
| Mengmeng Gu | Contact | 8602587726218 | gumengmeng322@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210006 | China |
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Both scales have a maximum score of 30 points, with lower scores indicating greater cognitive impairment. |
| From enrollment to 1 year |
| Fatigue severity was assessed using the 9-item Fatigue Severity Scale (FSS). | 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. | From enrollment to 1 year |
| Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD). | 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. | From enrollment to 1 year |
| Anxiety severity was assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA). | 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. | From enrollment to 1 year |