About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 30-80 years.
Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
Local residency ≥6 consecutive months.
Signed informed consent.
Disqualifiers
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.
Trial population
Patients with intracranial arterial stenosis recruited from the Department of Neurology, Nanjing First Hospital (Affiliated Nanjing Hospital of Nanjing Medical University)
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
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.
Secondary outcomes
Changes in Imaging Characteristics of Intracranial Vascular Plaques.
* 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 outcomes
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.
Cognitive function was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).
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).
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.
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.
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