Intracranial Artery StenosisNCT07085299
Gut Microbiota and Prognostic Outcomes in Intracranial Arterial Stenosis Patients（GROW-ICAS）
An observational study of Intracranial Artery Stenosis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Intracranial Artery Stenosis
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with intracranial arterial stenosis recruited from the Department of Neurology, Nanjing First Hospital (Affiliated Nanjing Hospital of Nanjing Medical University)
Who may be able to join
- Age 30-80 years.
- Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
- Local residency ≥6 consecutive months.
- Signed informed consent.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
Junshan Zhou, 8602587726218, zhjsh333@126.com
Mengmeng Gu, 8602587726218, gumengmeng322@yeah.net
About this study
Official title: Correlation Study Between Gut Microbiota and Prognosis in Patients With Intracranial Arterial Stenosis（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).
- Conditions
- Intracranial Artery Stenosis
- Keywords
- intracranial artery stenosis, Gut Microbiota
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From enrollment to 1 year
Secondary outcomes (1)
Changes in Imaging Characteristics of Intracranial Vascular Plaques.
- 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
Measured: From enrollment to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Artery StenosisStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085299
- Sponsor's protocol ID
- GROW-ICAS
- Status last verified
- Jun 2025
- First submitted
- 1 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study Between Gut Microbiota and Prognosis in Patients With Intracranial Arterial Stenosis（GROW-ICAS）
- ClinicalTrials.gov ID
- NCT07085299
- Acronym / sponsor ID
- GROW-ICAS
- Conditions
- Intracranial Artery Stenosis
- Keywords
- intracranial artery stenosis, Gut Microbiota
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with intracranial arterial stenosis recruited from the Department of Neurology, Nanjing First Hospital (Affiliated Nanjing Hospital of Nanjing Medical University)
Key inclusion criteria (4 listed)
- Age 30-80 years.
- Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
- Local residency ≥6 consecutive months.
- Signed informed consent.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
1 secondary outcome
Changes in Imaging Characteristics of Intracranial Vascular Plaques.
Time frame: From enrollment to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Artery Stenosis, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junshan Zhou (8602587726218, zhjsh333@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Recurrence in Patients with Symptomatic Intracranial Arterial Stenosis (time frame: From enrollment to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.