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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorNanjing First Hospital, Nanjing Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment to 1 year
2

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.

Time frame
From enrollment to 1 year

Secondary outcomes

1

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

Time frame
From enrollment to 1 year

Other outcomes

1

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.

Time frame
From enrollment to 1 year
2

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.

Time frame
From enrollment to 1 year
3

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.

Time frame
From enrollment to 1 year
4

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.

Time frame
From enrollment to 1 year

Sponsors and contacts

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