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

NCT07085299 | Recruiting DMC

• 1 other identifier: GROW-ICAS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Intracranial Artery Stenosis

Keywords

intracranial artery stenosis; Gut Microbiota

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Changes in Imaging Characteristics of Intracranial Vascular Plaques.

  From enrollment to 1 year

Other Outcomes (5)

• Functional outcomes were assessed using the modified Rankin Scale (mRS).

  From enrollment to 1 year

• Cognitive function was assessed using the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).

  From enrollment to 1 year

• Fatigue severity was assessed using the 9-item Fatigue Severity Scale (FSS).

  From enrollment to 1 year

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with intracranial arterial stenosis recruited from the Department of Neurology, Nanjing First Hospital (Affiliated Nanjing Hospital of Nanjing Medical University)

You may qualify if:

• Age 30-80 years.
• Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
• Local residency ≥6 consecutive months.
• Signed informed consent.

You may not qualify if:

• 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.
• Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
• Cardioembolic embolism.
• Active bleeding/hemorrhagic diathesis.
• Major surgery within 30 days pre-enrollment or planned within 6 months post-enrollment.
• Severe neurological deficits impairing independent living or dementia/psychiatric disorders hindering follow-up.
• Pregnancy/lactation/planned pregnancy.
• Chronic inflammatory/autoimmune diseases.
• Uncontrolled hypertension or diabetes.
• Severe cardiac/hepatic/renal dysfunction, hematologic disorders, malignancy, or life expectancy \<1 year.
• MRI contraindications.
• History of depression/anxiety/cognitive impairment requiring therapy.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

Central Study Contacts

Junshan Zhou

CONTACT

8602587726218; zhjsh333@126.com

Mengmeng Gu

CONTACT

8602587726218; gumengmeng322@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)