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

NCT ID: NCT07085299

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2028-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Intracranial Artery Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junshan Zhou

Role: CONTACT

8602587726218

Mengmeng Gu

Role: CONTACT

8602587726218

Facility Contacts

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Junshan Zhou

Role: primary

8602587726218

Mengmeng Gu

Role: backup

8602587726218

Other Identifiers

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GROW-ICAS

Identifier Type: -

Identifier Source: org_study_id

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