Cerebrovascular DiseaseNCT04443439
Assess the Risk of Cerebrovascular Disease
An observational study of Cerebrovascular Disease, run by Tang-Du Hospital at 1 site in China.
Trial summary
Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- GE Discovery MR750 3.0t superconducting MRI
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 1 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: No carotid stenosis - related neurological symptoms and transient ischemic attacks (50 patients in each group, 25 males and 25 females).
Who may be able to join
- Mild stenosis group: CTA suggested carotid stenosis < 30%;
- Moderate stenosis group: CTA suggested carotid stenosis of 30-69%;
- Severe stenosis group: CTA indicated carotid stenosis ≥70%;
Who cannot join
- dementia, MMSE score < 21;
- previous carotid stenosis related neurological symptoms or transient ischemic attack;
- other craniocerebral lesions, such as craniocerebral trauma, tumor, inflammation, and complications of great vessels (cerebral infarction or cerebral malacia);
- contraindications for MRI examination;
- recent use of psychoactive drugs or hormones.
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
Wen Wang
Xi'an, 710038
Wen Wang, Ph.D., +8618629066628 ext. +8618629066628, wangwen@fmmu.edu.cn
About this study
Official title: Head and Neck CTA Combined With Multimodal MRI to Assess the Risk of Cerebrovascular Disease
Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke. Asymptomatic carotid stenosis (ACS) refers to does not appear related neurological symptoms of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not happen cerebrovascular events such as stroke, but there have been a different degree of cognitive impairment, be badly in need of development of noninvasive imaging methods, objective evaluation of the ACS group cognitive impairment, and predict the ACS risk of ischemic stroke. Therefore, this topic proposed comprehensive cognitive assessment, CTA, double modal MRI techniques, clinical and biochemical indicator detection, mathematical modeling and statistical analysis techniques, assess the ACS group and normal person the cognitive ability, the difference of NVC and local perfusion, and follow-up ACS crowd of ischemic stroke and other cardiovascular events, discuss ACS and cognitive impairment, the correlation of NVC and local perfusion abnormalities, screening of radiographic predictor of ischemic stroke, and in the follow-up of ACS population in testing the sensitivity of the series of indicators and specific degrees.
- Conditions
- Cerebrovascular Disease
- Being tested
- GE Discovery MR750 3.0t superconducting MRI
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE Discovery MR750 3.0t superconducting MRIDevice
T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions
| Study group | Role | What they receive |
|---|---|---|
| No related neurological symptoms and transient ischemic attack | Mild stenosis group: CTA suggested carotid stenosis < 30%; Moderate stenosis group: CTA suggested carotid stenosis of 30-69%; Severe stenosis group: CTA indicated carotid stenosis ≥70%; Receives: Device: GE Discovery MR750 3.0t superconducting MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment
The Montreal cognitive assessment (MoCA) scale was used to evaluate the differences in cognitive function between ACS and the healthy control group in different dimensions, and the horizontal correlation analysis between ACS and cognitive impairment was conducted according to the dimensions of cognitive impairment and the degree of ACS.
Measured: 2020.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start9 Oct 2020
- Primary completion15 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Wang, MD & PhD, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443439
- Sponsor's protocol ID
- 2018LCYJ005
- Status last verified
- Oct 2022
- First submitted
- 27 May 2020
- Last updated
- 25 Oct 2022
- 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Neck CTA Combined With Multimodal MRI to Assess the Risk of Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT04443439
- Acronym / sponsor ID
- 2018LCYJ005
- Conditions
- Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Jun 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.
Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke. Asymptomatic carotid stenosis (ACS) refers to does not appear related neurological symptoms of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not happen cerebrovascular events such as stroke, but there have been a different degree of cognitive impairment, be badly in need of development of noninvasive imaging methods, objective evaluation of the ACS group cognitive impairment, and predict the ACS risk of ischemic stroke. Therefore, this topic proposed comprehensive cognitive assessment, CTA, double modal MRI techniques, clinical and biochemical indicator detection, mathematical modeling and statistical analysis techniques, assess the ACS group and normal person the cognitive ability, the difference of NVC and local perfusion, and follow-up ACS crowd of ischemic stroke and other cardiovascular events, discuss ACS and cognitive impairment, the correlation of NVC and local perfusion abnormalities, screening of radiographic predictor of ischemic stroke, and in the follow-up of ACS population in testing the sensitivity of the series of indicators and specific degrees.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No related neurological symptoms and transient ischemic attack | – | Device: GE Discovery MR750 3.0t superconducting MRIMild stenosis group: CTA suggested carotid stenosis < 30%; Moderate stenosis group: CTA suggested carotid stenosis of 30-69%; Severe stenosis group: CTA indicated carotid stenosis ≥70%; |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- No carotid stenosis - related neurological symptoms and transient ischemic attacks (50 patients in each group, 25 males and 25 females).
Key inclusion criteria (3 listed)
- Mild stenosis group: CTA suggested carotid stenosis < 30%;
- Moderate stenosis group: CTA suggested carotid stenosis of 30-69%;
- Severe stenosis group: CTA indicated carotid stenosis ≥70%;
Key exclusion criteria (5 listed)
- dementia, MMSE score < 21;
- previous carotid stenosis related neurological symptoms or transient ischemic attack;
- other craniocerebral lesions, such as craniocerebral trauma, tumor, inflammation, and complications of great vessels (cerebral infarction or cerebral malacia);
- contraindications for MRI examination;
- recent use of psychoactive drugs or hormones.
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 |
|---|---|---|
| GE Discovery MR750 3.0t superconducting MRIT2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions | Device | No related neurological symptoms and transient ischemic attack |
Primary outcome
Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment
Time frame: 2020.01
The Montreal cognitive assessment (MoCA) scale was used to evaluate the differences in cognitive function between ACS and the healthy control group in different dimensions, and the horizontal correlation analysis between ACS and cognitive impairment was conducted according to the dimensions of cognitive impairment and the degree of ACS.
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 Oct 2022.
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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 Cerebrovascular Disease, run by Tang-Du 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 3 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: looking for participants now, as of the sponsor's last update on 25 Oct 2022. 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 Wen Wang, Ph.D. (+8618629066628 ext. +8618629066628, wangwen@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment (time frame: 2020.01). 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 Oct 2022.