Carotid Artery StenosisNCT04651998
Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning
An observational study of Carotid Artery Stenosis, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial summary
Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- MMSE, MoCA, functional near-infrared spectroscopy
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 30 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high grade carotid artery stenosis treated with carotid artery stent from 5 hospitals.
Who may be able to join
- 35-80 years old
- Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard)
- Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA
- Agree to participate in the clinical trial and sign the informed consent
Who cannot join
- Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%)
- Left ventricular ejection fraction < 50% or heart failure
- Other types of dementia have been diagnosed
- Severe depression, mental illness, epilepsy
- Not cooperating with cognitive task evaluation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 6th People's Hospital
Shanghai, 200023
Yue-Qi Zhu, Dr., 0086-021-64844183, zyq1111@126.com
Yue-Qi Zhu, Dr
About this study
Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.
Read the detailed description
Patients with high grade internal carotid artery stenosis intended to carotid artery stent are brought to this study. Global cognitive function and evoked cerebral blood oxygenation are evaluated before and after stent, followed up at 6 months later. Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment (MoCA) are used for the global cognitive test. Evoked cerebral blood oxygenation is evaluated using functional near-infrared spectroscopy(fNIRS) through performing mental task( N-back task, Go/no go task, and verbal fluency task ). All the patients from different centers are conducted the test at the only main center by one doctor. The parameter of fNIRS and score of cognitive test of each patient are compared before and after stent.
- Conditions
- Carotid Artery Stenosis
- Being tested
- MMSE, MoCA, functional near-infrared spectroscopy
- Keywords
- carotid artery stent, functional near-infrared spectroscopy, vascular cognitive impairment,
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSE, MoCA, functional near-infrared spectroscopyDiagnostic test
MMSE and MoCA are used for cognitive test before carotid artery stent implant and 6 months later. Cerebral blood oxygenation is evaluated by functional near-infrared spectroscopy under the mental task before and after revascularization within one week, 6 months later respectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cognitive function score
Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function
Measured: MMSE score at baseline, 6 months after revascularization. Change of the score is calculated.
Secondary outcomes (3)
Parameter of evoked cerebral blood oxygenation
Means of HbO detected by functional near-infrared spectroscopy
Measured: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Parameter of evoked cerebral blood oxygenation
Skewness of HbO detected by functional near-infrared spectroscopy
Measured: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Parameter of evoked cerebral blood oxygenation
kurtosis of HbO detected by functional near-infrared spectroscopy
Measured: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 May 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- 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
- 74 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, RenJi Hospital, ShuGuang Hospital
- Responsible party
- Principal investigator, Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Yueqi Zhu, PhD, Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651998
- Sponsor's protocol ID
- CAS-fNIRS
- Status last verified
- Jun 2023
- First submitted
- 24 Nov 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning
- ClinicalTrials.gov ID
- NCT04651998
- Acronym / sponsor ID
- CAS-fNIRS
- Conditions
- Carotid Artery Stenosis
- Keywords
- carotid artery stent, functional near-infrared spectroscopy, vascular cognitive impairment,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Collaborators
- Fudan University, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, RenJi Hospital, ShuGuang Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Dec 2020 (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.
Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.
Detailed description
Patients with high grade internal carotid artery stenosis intended to carotid artery stent are brought to this study. Global cognitive function and evoked cerebral blood oxygenation are evaluated before and after stent, followed up at 6 months later. Mini-Mental State Examination(MMSE) and Montreal Cognitive Assessment (MoCA) are used for the global cognitive test. Evoked cerebral blood oxygenation is evaluated using functional near-infrared spectroscopy(fNIRS) through performing mental task( N-back task, Go/no go task, and verbal fluency task ). All the patients from different centers are conducted the test at the only main center by one doctor. The parameter of fNIRS and score of cognitive test of each patient are compared before and after stent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high grade carotid artery stenosis treated with carotid artery stent from 5 hospitals.
Key inclusion criteria (4 listed)
- 35-80 years old
- Severe carotid stenosis (MRA or CTA confirmed stenosis rate of 70% - 99%, NASCET standard)
- Asymptomatic or mild stroke (NIHSS ≤ 3) or TIA
- Agree to participate in the clinical trial and sign the informed consent
Key exclusion criteria (5 listed)
- Severe stenosis or occlusion of vertebrobasilar artery and other intracranial arteries (70% - 99%)
- Left ventricular ejection fraction < 50% or heart failure
- Other types of dementia have been diagnosed
- Severe depression, mental illness, epilepsy
- Not cooperating with cognitive task evaluation
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 |
|---|---|---|
| MMSE, MoCA, functional near-infrared spectroscopyMMSE and MoCA are used for cognitive test before carotid artery stent implant and 6 months later. Cerebral blood oxygenation is evaluated by functional near-infrared spectroscopy under the mental task before and after revascularization within one week, 6 months later respectively. | Diagnostic test | – |
Primary outcome
Change of cognitive function score
Time frame: MMSE score at baseline, 6 months after revascularization. Change of the score is calculated.
Mini-mental State Examination (0-30 points), the higher the score, the better the cognitive function
3 secondary outcomes
Parameter of evoked cerebral blood oxygenation
Time frame: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Parameter of evoked cerebral blood oxygenation
Time frame: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Parameter of evoked cerebral blood oxygenation
Time frame: Evoked cerebral blood oxygenation evaluated after stent immediately, 6 months later, compared with that at baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- 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. This study is not recruiting at the moment.
Yueqi Zhu, PhD principal investigator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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 Carotid Artery Stenosis, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 29 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiangshan Deng, PhD (862164369181, johnson120@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of cognitive function score (time frame: MMSE score at baseline, 6 months after revascularization. Change of the score is calculated.). 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 29 May 2024.