Intracranial Atherosclerotic StenosisNCT07125339
High-resolution Magnetic Resonance Vessel Wall Imaging of Plaques
An observational study of Intracranial Atherosclerotic Stenosis, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial summary
The primary objective of this study is to investigate the predictive value of High-resolution magnetic resonance vessel wall imaging for future stroke occurrence in patients with moderate to severe intracranial and extracranial artery stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Atherosclerotic Stenosis
- How many people
- 605 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2025to 1 Jun 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate to severe stenosis (stenosis degree: 50% ~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.
Who may be able to join
- At least 18 years old;
- Medium or severe stenosis of the internal carotid artery, middle cerebral artery, V4 segment of vertebral artery or basilar artery [stenosis degree: 50% ~ 99%, confirmed by CTA, MRA or DSA];
- Accept high resolution magnetic resonance angiography; The patient or the legal representative of the patient is able and willing to sign an informed consent form
Who cannot join
- Non-atherosclerotic intracranial and extracranial artery stenosis, such as dissection, smoke disease, etc.;
- There are contraindications to MRI, such as claustrophobia, metal implants, etc.;
- Renal insufficiency, elevated serum creatinine (more than twice the upper limit of normal);
- Patients with severe cardiopulmonary diseases were considered unsuitable for this study;
- Gadolinium contrast agent allergy;
- Participants who were unable to complete the study due to mental illness, cognitive or emotional disorder.
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
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, 20023
Yue-Qi Zhu, MD, 0086-021-64844183, zyq1111@126.com
Yue-Qi Zhu, MD
About this study
Official title: High-resolution Magnetic Resonance Vessel Wall Imaging of Intracranial and Extracranial Plaques: a Prospective Cohort Registration Study
The primary objective of this study is to investigate the predictive value of High-resolution magnetic resonance vessel wall imaging for future stroke occurrence in patients with moderate to severe intracranial and extracranial artery stenosis.
The secondary objective is to explore the predictive value of baseline high-resolution magnetic resonance vessel wall imaging for plaque progression.
Read the detailed description
Carotid artery origin and intracranial atherosclerotic stenosis (ICAS) are among the leading causes of ischemic cerebrovascular events worldwide, with ICAS accounting for up to 46.6% of ischemic stroke or transient ischemic attacks (TIA) cases in China. Vascular imaging-defined lumen narrowing and clinical manifestations have long been recognized as primary contributors to subsequent ischemic cerebrovascular events. While it is widely accepted that most ischemic events result from ruptured atherosclerotic plaques, hemodynamic disturbances caused by plaque progression within and beyond the cranium, collateral or perforator occlusions, and distal embolism from plaque detachment also play significant roles. Current clinical decision-making relying solely on lumen narrowing dimensions presents substantial limitations. Compared to lumen narrowing alone, detailed characterization of plaque morphology and composition correlates more closely with clinical presentations and subsequent ischemic events.
Advanced high-resolution vessel wall imaging (HR-VWI) technology has achieved 2D and 3D imaging of intracranial and extracranial arterial walls. By suppressing blood flow within the vessels, it can clearly display the morphology and signal characteristics of the vascular walls: Non-invasively describe the detailed structure of atherosclerosis, identifying plaque components, enhancement intensity, reconstruction type, and load, while evaluating the characteristics of vulnerable plaques in extracranial carotid arteries and ICAS, such as intraplaque hemorrhage (IPH), lipid-rich necrotic core (LRNC), and ulcers. Previous studies have shown that these plaque features can provide additional value for distinguishing between stroke cases and asymptomatic patients with narrowed arteries.
However, most of these studies are cross-sectional in nature, and due to limited data, their conclusions vary. Some reports suggest that symptomatic ICAS patients with plaque enhancement may be more related to future ischemic events, while other studies argue that the correlation is minimal. Additionally, previous research investigating the temporal changes in plaque characteristics and their relationship with recurrent stroke has been constrained by small sample sizes (N <15), leading to inconclusive conclusions.
Therefore, more comprehensive studies are needed to evaluate the value of baseline HR-VWI in identifying patients with intracranial and extracranial arterial stenosis at risk of ischemic cerebrovascular events in the future. Through wall plaque imaging studies, it is expected that multi-modal imaging can be used to stratify stroke risk based on cerebral vascular plaques.
- Conditions
- Intracranial Atherosclerotic Stenosis
- Keywords
- high resolution vessel wall imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stroke group | Patients with moderate to severe stenosis (stenosis degree: 50% ~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumen Stenosis Rate
The lumen stenosis rate is calculated using the 3D TOF-MRA measurement of the vertebral-basilar artery's narrowest diameter and the normal diameter at the proximal end. The calculation follows the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) standard formula: Lumen Stenosis Rate = [1- (Narrowest Diameter / Normal Diameter at Proximal End)] × 100%
Measured: 2024.08-2027.12
Identify different plaque components
Measured: 2024.08-2027.12
Secondary outcomes (5)
Ejection index and maximum wall thickness
Select the narrowest lumen level and manually outline the lumen and wall boundary at the narrowest point. Ejection index = (maximum wall thickness-minimum wall thickness)/ maximum wall thickness
Measured: 2024.08-2027.12
Wall thickness
maximum wall thickness, minimum wall thickness and average wall thickness
Measured: 2024.08-2027.12
Patch load
Select the narrowest lumen level and manually outline the lumen and wall boundaries at the narrowest point. Mainly measure the lumen area (LA), wall area (WA), and normalized wall index (NWI). NWI = WA / (WA + LA) × 100%
Measured: 2024.08-2027.12
Vascular reconstruction index RR
measured by the ratio of the outer wall area of the blood vessel in the lesion to that of the adjacent normal blood vessel
Measured: 2024.08-2027.12
Plaque-to-pituitary stalk contrast enhancement ratio (CR)
CR = (SI plaque post / SI stalk post) × 100%; signal intensity (signal intensity, SI)
Measured: 2024.08-2027.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Atherosclerotic 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
- 605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueqi Zhu, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Yueqi Zhu, MD, Principal investigator, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125339
- Sponsor's protocol ID
- HELP Study
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 15 Aug 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Magnetic Resonance Vessel Wall Imaging of Intracranial and Extracranial Plaques: a Prospective Cohort Registration Study
- ClinicalTrials.gov ID
- NCT07125339
- Acronym / sponsor ID
- HELP Study
- Conditions
- Intracranial Atherosclerotic Stenosis
- Keywords
- high resolution vessel wall imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 605 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 15 Aug 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.
The primary objective of this study is to investigate the predictive value of High-resolution magnetic resonance vessel wall imaging for future stroke occurrence in patients with moderate to severe intracranial and extracranial artery stenosis.
The secondary objective is to explore the predictive value of baseline high-resolution magnetic resonance vessel wall imaging for plaque progression.
Detailed description
Carotid artery origin and intracranial atherosclerotic stenosis (ICAS) are among the leading causes of ischemic cerebrovascular events worldwide, with ICAS accounting for up to 46.6% of ischemic stroke or transient ischemic attacks (TIA) cases in China. Vascular imaging-defined lumen narrowing and clinical manifestations have long been recognized as primary contributors to subsequent ischemic cerebrovascular events. While it is widely accepted that most ischemic events result from ruptured atherosclerotic plaques, hemodynamic disturbances caused by plaque progression within and beyond the cranium, collateral or perforator occlusions, and distal embolism from plaque detachment also play significant roles. Current clinical decision-making relying solely on lumen narrowing dimensions presents substantial limitations. Compared to lumen narrowing alone, detailed characterization of plaque morphology and composition correlates more closely with clinical presentations and subsequent ischemic events.
Advanced high-resolution vessel wall imaging (HR-VWI) technology has achieved 2D and 3D imaging of intracranial and extracranial arterial walls. By suppressing blood flow within the vessels, it can clearly display the morphology and signal characteristics of the vascular walls: Non-invasively describe the detailed structure of atherosclerosis, identifying plaque components, enhancement intensity, reconstruction type, and load, while evaluating the characteristics of vulnerable plaques in extracranial carotid arteries and ICAS, such as intraplaque hemorrhage (IPH), lipid-rich necrotic core (LRNC), and ulcers. Previous studies have shown that these plaque features can provide additional value for distinguishing between stroke cases and asymptomatic patients with narrowed arteries.
However, most of these studies are cross-sectional in nature, and due to limited data, their conclusions vary. Some reports suggest that symptomatic ICAS patients with plaque enhancement may be more related to future ischemic events, while other studies argue that the correlation is minimal. Additionally, previous research investigating the temporal changes in plaque characteristics and their relationship with recurrent stroke has been constrained by small sample sizes (N <15), leading to inconclusive conclusions.
Therefore, more comprehensive studies are needed to evaluate the value of baseline HR-VWI in identifying patients with intracranial and extracranial arterial stenosis at risk of ischemic cerebrovascular events in the future. Through wall plaque imaging studies, it is expected that multi-modal imaging can be used to stratify stroke risk based on cerebral vascular plaques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke group | – | –Patients with moderate to severe stenosis (stenosis degree: 50% ~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe stenosis (stenosis degree: 50% ~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.
Key inclusion criteria (3 listed)
- At least 18 years old;
- Medium or severe stenosis of the internal carotid artery, middle cerebral artery, V4 segment of vertebral artery or basilar artery [stenosis degree: 50% ~ 99%, confirmed by CTA, MRA or DSA];
- Accept high resolution magnetic resonance angiography; The patient or the legal representative of the patient is able and willing to sign an informed consent form
Key exclusion criteria (6 listed)
- Non-atherosclerotic intracranial and extracranial artery stenosis, such as dissection, smoke disease, etc.;
- There are contraindications to MRI, such as claustrophobia, metal implants, etc.;
- Renal insufficiency, elevated serum creatinine (more than twice the upper limit of normal);
- Patients with severe cardiopulmonary diseases were considered unsuitable for this study;
- Gadolinium contrast agent allergy;
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
Lumen Stenosis Rate
Time frame: 2024.08-2027.12
The lumen stenosis rate is calculated using the 3D TOF-MRA measurement of the vertebral-basilar artery's narrowest diameter and the normal diameter at the proximal end. The calculation follows the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) standard formula: Lumen Stenosis Rate = [1- (Narrowest Diameter / Normal Diameter at Proximal End)] × 100%
Identify different plaque components
Time frame: 2024.08-2027.12
5 secondary outcomes
Ejection index and maximum wall thickness
Time frame: 2024.08-2027.12
Wall thickness
Time frame: 2024.08-2027.12
Patch load
Time frame: 2024.08-2027.12
Vascular reconstruction index RR
Time frame: 2024.08-2027.12
Plaque-to-pituitary stalk contrast enhancement ratio (CR)
Time frame: 2024.08-2027.12
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 15 Aug 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.
Yueqi Zhu, MD 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 Intracranial Atherosclerotic 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Aug 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 Yueqi Zhu, MD (0086-21-64844183, zhuyueqi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumen Stenosis Rate (time frame: 2024.08-2027.12). 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 15 Aug 2025.