Actively Recruiting

Age: 30Years - 80Years
All Genders
ID07085299

Correlation Study Between Gut Microbiota and Prognosis in Patients With Intracranial Arterial Stenosis (GROW-ICAS)

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-07-25

500

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study, GROW-ICAS, enrolls patients aged 30 to 80 years with intracranial arterial stenosis to examine how gut microbiota and related biological profiles relate to important clinical aspects. The research focuses on functional outcomes, vascular plaque imaging features, and post-stroke non-motor problems such as cognitive impairment, depression, anxiety, and fatigue. Researchers aim to better understand these connections to improve prognosis for affected patients. Participants do not receive specific treatments but are monitored to collect detailed data on their gut microbiota, metabolomic, and transcriptomic profiles alongside imaging and clinical assessments. The study follows patients for at least one year to observe stroke recurrence in those with symptomatic or asymptomatic intracranial arterial stenosis and changes in vascular plaque characteristics. There is no intervention; rather, the study observes natural progression and associations. During the study, participants undergo imaging scans to confirm intracranial arterial stenosis and regular evaluations to assess functional status, cognitive and emotional health, and vascular plaque changes. Researchers collect biological samples and clinical data to analyze correlations with outcomes. Safety and eligibility are assessed by excluding those with recent bleeding, other major medical conditions, or treatments that might interfere. The overall participation spans at least one year from enrollment with ongoing monitoring of stroke events and vascular health.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 30 to 80 years
  • Intracranial arterial stenosis confirmed by CTA, MRA, or DSA
  • Resident locally for at least 6 consecutive months
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Tandem extracranial stenosis (50% or more) near the target intracranial vessel
  • Non-atherosclerotic intracranial stenosis
  • Endovascular treatment within 30 days before enrollment or planned within 6 months after
  • Intracranial hemorrhage within 90 days before enrollment
  • Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation
  • Cardioembolic embolism
  • Active bleeding or bleeding disorders
  • Major surgery within 30 days before enrollment or planned within 6 months after
  • Severe neurological deficits or dementia/psychiatric disorders that affect follow-up
  • Pregnancy, breastfeeding, or planned pregnancy
  • Chronic inflammatory or autoimmune diseases
  • Uncontrolled high blood pressure or diabetes
  • Severe heart, liver, kidney problems, blood disorders, cancer, or life expectancy less than 1 year
  • MRI contraindications
  • History of depression, anxiety, or cognitive impairment requiring therapy
  • Use of antibiotics, probiotics, steroids, or immunosuppressants within 1 month before enrollment
  • Current or planned participation in other clinical trials
  • Inability to cooperate due to psychiatric or emotional disorders
  • Other reasons deemed ineligible by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year

Participants undergo imaging and assessments to evaluate intracranial arterial stenosis and related characteristics.

Periodic imaging and assessments during the year

Long-term Monitoring

Duration - Up to 1 year

Participants are monitored for stroke recurrence and changes in health status related to intracranial arterial stenosis.

Follow-up visits for up to 1 year after enrollment

Trial Site Locations

Total: 1 location

1

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China, 210006

Actively Recruiting

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Research Team

J

Junshan Zhou

M

Mengmeng Gu

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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