Carotid StenosisNCT06452173
Risk Prediction Model for Cerebrovascular Events in Carotid Artery Stenosis
An observational study of Carotid Stenosis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Atherosclerotic carotid artery stenosis is a major cause of stroke, and early identification of high-risk patients combined with surgical intervention can significantly reduce stroke risk. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- Plasma and carotid high-resolution magnetic resonance imaging
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 31 Dec 2026
- How long will I take part?
- 1 Week
- 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: All patients who met the enrollment criteria at Beijing Tiantan Hospital.
Who may be able to join
- Patients diagnosed with atherosclerotic carotid stenosis;
- Those who signed informed consent and volunteered to participate in this study.
Who cannot join
- Patients with combined severe stenosis of intracranial arteries;
- Patients with combined cardiogenic embolism, vasculitis, entrapment aneurysm and other related cerebral infarction;
- Combination of tumors, rheumatic immune system diseases, hematologic diseases and other diseases that change blood metabolism and proteomic characteristics;
- There are contraindications to magnetic resonance scanning and allergy to gadolinium contrast agent;
- Inability to cooperate in completing the relevant examinations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Deep Learning-based Risk Prediction Model for Cerebrovascular Events in Patients With Carotid Artery Stenosis
Atherosclerotic carotid artery stenosis is a major cause of stroke, and early identification of high-risk patients combined with surgical intervention can significantly reduce stroke risk. Currently, stroke risk assessment in patients with carotid artery stenosis primarily relies on imaging indicators such as plaque morphology, composition, and degree of stenosis, with less emphasis on indicators directly related to inflammation, hemodynamics, and plaque instability. Certain circulating metabolites are closely linked to plaque progression and are direct risk factors for stroke. However, there is a lack of stroke risk prediction models for patients with carotid stenosis that incorporate these indicators, and the ability to identify high-risk patients needs improvement.
This study proposes using deep learning technology to integrate multidimensional data from plaque imaging, fluid dynamics, circulating metabolomics, and proteomics to construct an accurate prediction model for cerebrovascular events in patients with carotid artery stenosis. Additionally, it aims to explore markers of plaque instability characteristics based on plaque pathology. The study is expected to provide a basis for identifying high-risk patients with carotid artery stenosis, thereby laying the foundation for reducing stroke risk and improving long-term patient outcomes.
- Conditions
- Carotid Stenosis
- Being tested
- Plasma, carotid high-resolution magnetic resonance imaging
- Keywords
- carotid stenosis, stroke, Risk prediction model, Deep-learning
- Medical subject headings
- Carotid Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaDiagnostic test
Plasma levels of metabolites and some proteins will be further determined
carotid high-resolution magnetic resonance imagingDiagnostic test
Define plaque composition and morphological characteristics
| Study group | Role | What they receive |
|---|---|---|
| high risk | Patients with cerebrovascular events within six months, including i. cerebral infarction in the middle cerebral artery territory on the side of carotid stenosis; ii. transient ischemic attack symptoms (including motor and sensory) in the hemisphere on the side of stenosis; and iii. transient amaurosis on the side of stenosis. This indicates an unstable condition and such patients are defined as high-risk carotid stenosis patients. Receives: Diagnostic Test: Plasma; Diagnostic Test: carotid high-resolution magnetic resonance imaging | |
| low risk | Patients without cerebrovascular events within six months are defined as low-risk carotid stenosis patients. Receives: Diagnostic Test: Plasma; Diagnostic Test: carotid high-resolution magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Cerebrovascular Events
Patients will be categorized as having a cerebrovascular event if they meet one of the following indicators:
- cerebral infarction in the middle cerebral artery territory on the side of carotid stenosis; ii. transient ischemic attack symptoms (including motor and sensory) in the hemisphere on the side of stenosis; and iii. transient amaurosis on the side of stenosis.
Measured: Within six months from the date of consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start15 Apr 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Neurosurgical Institute
- Responsible party
- Sponsor
- Investigators
- Yan Zhang, MD, Principal investigator, Beijing Neurosurgical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452173
- Sponsor's protocol ID
- KY2024-070-02
- Other IDs
- 2024-2-1072
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning-based Risk Prediction Model for Cerebrovascular Events in Patients With Carotid Artery Stenosis
- ClinicalTrials.gov ID
- NCT06452173
- Acronym / sponsor ID
- KY2024-070-02
- Conditions
- Carotid Stenosis
- Keywords
- carotid stenosis, stroke, Risk prediction model, Deep-learning
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Neurosurgical Institute
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Jun 2024 (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.
Atherosclerotic carotid artery stenosis is a major cause of stroke, and early identification of high-risk patients combined with surgical intervention can significantly reduce stroke risk. Currently, stroke risk assessment in patients with carotid artery stenosis primarily relies on imaging indicators such as plaque morphology, composition, and degree of stenosis, with less emphasis on indicators directly related to inflammation, hemodynamics, and plaque instability. Certain circulating metabolites are closely linked to plaque progression and are direct risk factors for stroke. However, there is a lack of stroke risk prediction models for patients with carotid stenosis that incorporate these indicators, and the ability to identify high-risk patients needs improvement.
This study proposes using deep learning technology to integrate multidimensional data from plaque imaging, fluid dynamics, circulating metabolomics, and proteomics to construct an accurate prediction model for cerebrovascular events in patients with carotid artery stenosis. Additionally, it aims to explore markers of plaque instability characteristics based on plaque pathology. The study is expected to provide a basis for identifying high-risk patients with carotid artery stenosis, thereby laying the foundation for reducing stroke risk and improving long-term patient outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high risk | – | Diagnostic Test: Plasma, Diagnostic Test: carotid high-resolution magnetic resonance imagingPatients with cerebrovascular events within six months, including i. cerebral infarction in the middle cerebral artery territory on the side of carotid stenosis; ii. transient ischemic attack symptoms (including motor and sensory) in the hemisphere on the side of stenosis; and iii. transient amaurosis on the side of stenosis. This indicates an unstable condition and such patients are defined as high-risk carotid stenosis patients. |
| low risk | – | Diagnostic Test: Plasma, Diagnostic Test: carotid high-resolution magnetic resonance imagingPatients without cerebrovascular events within six months are defined as low-risk carotid stenosis patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who met the enrollment criteria at Beijing Tiantan Hospital.
Key inclusion criteria (2 listed)
- Patients diagnosed with atherosclerotic carotid stenosis;
- Those who signed informed consent and volunteered to participate in this study.
Key exclusion criteria (5 listed)
- Patients with combined severe stenosis of intracranial arteries;
- Patients with combined cardiogenic embolism, vasculitis, entrapment aneurysm and other related cerebral infarction;
- Combination of tumors, rheumatic immune system diseases, hematologic diseases and other diseases that change blood metabolism and proteomic characteristics;
- There are contraindications to magnetic resonance scanning and allergy to gadolinium contrast agent;
- Inability to cooperate in completing the relevant examinations.
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 |
|---|---|---|
| PlasmaPlasma levels of metabolites and some proteins will be further determined | Diagnostic test | high risk, low risk |
| carotid high-resolution magnetic resonance imagingDefine plaque composition and morphological characteristics | Diagnostic test | high risk, low risk |
Primary outcome
Number of Patients with Cerebrovascular Events
Time frame: Within six months from the date of consultation
Patients will be categorized as having a cerebrovascular event if they meet one of the following indicators: i. cerebral infarction in the middle cerebral artery territory on the side of carotid stenosis; ii. transient ischemic attack symptoms (including motor and sensory) in the hemisphere on the side of stenosis; and iii. transient amaurosis on the side of stenosis.
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 13 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Carotid Stenosis
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruiting
Optical Coherence Tomography-Assisted Strategy for Interventional Management of Symptomatic Carotid Stenosis (OASIS-C)
Carotid Stenosis
Not yet recruitingObservational study
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
Carotid Stenosis
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.
Yan Zhang, MD principal investigator
Beijing Neurosurgical Institution
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 Stenosis, run by Beijing Tiantan 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 2 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: enrolling by invitation, as of the sponsor's last update on 13 Jun 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Cerebrovascular Events (time frame: Within six months from the date of consultation). 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 13 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.