Cognitive FunctionNCT05322824
Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
An observational study of Cognitive Function and Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cognitive Function, Stenosis
- What is being tested?
- standard medical treatment and Interventional stenting
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2029
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intracranial / carotid stenosis aged ≥ 40 years
Who may be able to join
- Patients aged ≥ 40 years
- ≥ 50% stenosis in unilateral intracranial / carotid artery
- Written informed consent available
Who cannot join
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- Severe loss of vision, hearing, or communicative ability
- Exit Criteria:
- Not meet the inclusion criteria
- For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
- Any adverse or serious adverse events during the study period judged by investigator
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
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
Min Lou, PhD, MD, 13958007213, lm99@zju.edu.cn
About this study
Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. The investigators aim to analyze clinical and imaging characteristics of patients with cognitive impairment related to intracranial/carotid stenosis, in order to achieve early identification of cognitive impairment.
- Conditions
- Cognitive Function, Stenosis
- Being tested
- standard medical treatment, Interventional stenting
- Keywords
- Cognitive Function, Intracranial / Carotid Stenosis
- Medical subject headings
- Constriction, Pathologic, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard medical treatmentDrug
standard medical treatment
Interventional stentingProcedure or surgery
Interventional stenting
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the scores of Mini-mental State Examination
Total score of 30. Higher scores mean a better outcome.
Measured: 2 years
Secondary outcomes (10)
Incidence of stroke event including ischemic and hemorrhagic stroke
Measured: 2 years
Changes in cerebral glymphatic function
assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Measured: 2 years
Changes in the scores of Montreal Cognitive Assessment
Total score of 30
Measured: 2 years
Changes in cerebral blood flow in the territory of the culprit artery
Measured: 2 years
Changes in the scores of Colour Trail Test
Measured: 2 years
Changes in the scores of Hopkins Verbal Learning Test
Measured: 2 years
Changes in the scores of clock drawing test
Measured: 2 years
Changes in the scores of Animal Fluency Test
Measured: 2 years
Changes in the scores of Olfactory stick test
Measured: 2 years
Changes in metabonomics
include blood and fecal samples
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- NCT05322824
- Sponsor's protocol ID
- ROSE
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Registration Study of Patients With Intracranial / Carotid Stenosis
- ClinicalTrials.gov ID
- NCT05322824
- Acronym / sponsor ID
- ROSE
- Conditions
- Cognitive Function, Stenosis
- Keywords
- Cognitive Function, Intracranial / Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Apr 2022 (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.
Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. The investigators aim to analyze clinical and imaging characteristics of patients with cognitive impairment related to intracranial/carotid stenosis, in order to achieve early identification of cognitive impairment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intracranial / carotid stenosis aged ≥ 40 years
Key inclusion criteria (3 listed)
- Patients aged ≥ 40 years
- ≥ 50% stenosis in unilateral intracranial / carotid artery
- Written informed consent available
Key exclusion criteria (8 listed)
- Previous history of major head trauma and any intracranial surgery
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- Severe loss of vision, hearing, or communicative ability
- Not meet the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard medical treatmentstandard medical treatment | Drug | – |
| Interventional stentingInterventional stenting | Procedure or surgery | – |
Primary outcome
Changes in the scores of Mini-mental State Examination
Time frame: 2 years
Total score of 30. Higher scores mean a better outcome.
10 secondary outcomes
Incidence of stroke event including ischemic and hemorrhagic stroke
Time frame: 2 years
Changes in cerebral glymphatic function
Time frame: 2 years
Changes in the scores of Montreal Cognitive Assessment
Time frame: 2 years
Changes in cerebral blood flow in the territory of the culprit artery
Time frame: 2 years
Changes in the scores of Colour Trail Test
Time frame: 2 years
Changes in the scores of Hopkins Verbal Learning Test
Time frame: 2 years
Changes in the scores of clock drawing test
Time frame: 2 years
Changes in the scores of Animal Fluency Test
Time frame: 2 years
Changes in the scores of Olfactory stick test
Time frame: 2 years
Changes in metabonomics
Time frame: 2 years
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 18 Apr 2023.
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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 Cognitive Function and Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 8 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 18 Apr 2023. 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 Min Lou, PhD, MD (13958007213, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the scores of Mini-mental State Examination (time frame: 2 years). 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 18 Apr 2023.