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Recruiting NCT07085299

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

— Observational Intracranial Artery Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intracranial Artery Stenosis. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Primary outcome measures

  • Stroke Recurrence in Patients with Symptomatic Intracranial Arterial Stenosis [Time frame: From enrollment to 1 year]
  • Stroke Occurrence in Patients with Asymptomatic Intracranial Arterial Stenosis [Time frame: From enrollment to 1 year]
Secondary outcome measures (1)
  • Changes in Imaging Characteristics of Intracranial Vascular Plaques. [Time frame: From enrollment to 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Nanjing First Hospital, Nanjing Medical University — Nanjing

Identifiers

NCT: NCT07085299 · GROW-ICAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗