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NCT Number: NCT07085299

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

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).

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Key information

Conditions

Intracranial Artery Stenosis

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • Antibiotic/probiotic/glucocorticoid/immunosuppressant use within 1 month pre-enrollment.
  • Current/planned participation in other trials.
  • Inability to cooperate due to psychiatric/emotional disorders.
  • Other investigator-deemed ineligibility.

Treatment and study plan

Primary outcomes

  1. Stroke Recurrence in Patients with Symptomatic Intracranial Arterial Stenosis

    Time frame: From enrollment to 1 year

    Patients with symptomatic intracranial arterial stenosis experiencing recurrent cerebrovascular events, defined as either novel ischemic stroke or transient ischemic attack (TIA).

  2. Stroke Occurrence in Patients with Asymptomatic Intracranial Arterial Stenosis

    Time frame: From enrollment to 1 year

    Incident cerebrovascular events-comprising ischemic stroke or transient ischemic attack (TIA)-occurring in patients exhibiting asymptomatic intracranial arterial stenosis.

Secondary outcomes

  1. Changes in Imaging Characteristics of Intracranial Vascular Plaques.

    Time frame: From enrollment to 1 year

    • 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

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

    Time frame: From enrollment to 1 year

    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.

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

    Time frame: From enrollment to 1 year

    Both scales have a maximum score of 30 points, with lower scores indicating greater cognitive impairment.

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

    Time frame: From enrollment to 1 year

    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.

  4. Depression severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD).

    Time frame: From enrollment to 1 year

    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.

  5. Anxiety severity was assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA).

    Time frame: From enrollment to 1 year

    The Hamilton Anxiety Rating Scale (HAMA-14) was administered to quantify anxiety severity. A direct correlation exists between total scores and clinical symptom burden, with elevated scores denoting increased severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Junshan Zhou

CONTACT

[email protected]

8602587726218

Mengmeng Gu

CONTACT

[email protected]

8602587726218

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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