ICAS - Intracranial AtherosclerosisNCT07309718
MPR for Stroke Risk Assessment of ICAS
An observational study of ICAS - Intracranial Atherosclerosis and Stroke Ischemic, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Intracranial atherosclerotic stenosis (ICAS) carries substantial stroke risk despite optimal medical treatment. Current risk stratification relies primarily on stenosis severity, but novel hemodynamic markers may improve prediction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ICAS - Intracranial Atherosclerosis, Stroke Ischemic, Hemodynamic
- What is being tested?
- Standardized medical therapy targeting vascular risk factors and stroke prevention
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Mar 2028
- How long will I take part?
- 12 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ICAS involving 50% to 99% stenosis of a major intracranial artery in the anterior circulation, including the internal carotid artery (ICA C6-C7 segment) and the middle cerebral artery M1 (MCA-M1) segment.
Who may be able to join
- Adults aged 18 to 80 years.
- Intracranial atherosclerotic stenosis ICAS involving a culprit artery in the anterior circulation.
- Intracranial arterial stenosis of 50% to 99% as measured by the WASID method using TCD, CTA, MRA, or DSA.
- Written informed consent obtained from the participant or a legal representative.
Who cannot join
- Non-atherosclerotic intracranial lesions, including moyamoya disease, vasculitis, vascular dissection, autoimmune diseases, or congenital/genetic abnormalities.
- More than 50% stenosis of the extracranial carotid artery on the ipsilateral side.
- Large cerebral infarction involving more than one-half of the territory on DWI imaging, or a baseline modified Rankin Scale score ≥3.
- Contraindications to antiplatelet therapy or statins.
- Inability to undergo MRI due to metal implants or claustrophobia.
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
Department of Neurosurgery, Xuanwu hospital
Beijing, Xicheng District, 100053
Jichang Luo, M.D., +86 13120136577, luojichang_dr@sina.com
About this study
Official title: MRI-Derived Pressure Ratio: a Novel Noninvasive Hemodynamic Biomarker for Stroke Risk Stratification in Intracranial Atherosclerotic Stenosis
Intracranial atherosclerotic stenosis (ICAS) carries substantial stroke risk despite optimal medical treatment. Current risk stratification relies primarily on stenosis severity, but novel hemodynamic markers may improve prediction. In this multiple prospective registry study we aim to investigate whether regional hemodynamics, measured by a novel Magnetic resonance imaging-derived Pressure Ratio (MPR) technique, are associated with stroke risk in ICAS.
Read the detailed description
This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 5 participating stroke centres , and plans to recruit 400 consecutive patients who meet the inclusion and exclusion criteria. After the enrolment, all participants would be evaluated at baseline, 1 month, 6 months, and 12 months post-enrollment. All participants received standardized medical therapy, including dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines. Multimodal imaging techniques were employed to assess hemodynamic status: luminal stenosis would be evaluated using transcranial Doppler (TCD), computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA), high-resolution MRI and phase-contrast MR angiography (PC-MRA) would be collected to calculate MPR. The primary outcomes were ischemic stroke in the qualifying artery territory or related death within 1 year. There were 5 secondary outcomes, including hemodynamic ischemic stroke in the qualifying artery territory within1 year. An independent Data and Safety Monitoring Board (DSMB) oversees the conduction, safety and efficacy of the study.
- Being tested
- Standardized medical therapy targeting vascular risk factors and stroke prevention
- Keywords
- ICAS - Intracranial Atherosclerosis, Stroke Ischemic, Hemodynamic, Pressure ratio
- Medical subject headings
- Intracranial Arteriosclerosis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized medical therapy targeting vascular risk factors and stroke preventionDrug
Dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines
| Study group | Role | What they receive |
|---|---|---|
| CASSISS-MPR | Not described Receives: Drug: Standardized medical therapy targeting vascular risk factors and stroke prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
Measured: 12 months
Secondary outcomes (5)
transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year
the number of participants who suffer from transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year after enrollment.
Measured: 12 months
TIA related to ischemia in the qualifying artery territory within 1 year
the number of participants who suffer from TIA related to ischemia in the qualifying artery territory within 1 year
Measured: 12 months
any stroke/TIA/ death within 1 year
the number of participants who suffer from any stroke/TIA/ death within 1 year
Measured: 12 months
hemodynamic ischemic stroke in the qualifying artery territory within 1 year
the number of participants who suffer from hemodynamic ischemic stroke in the qualifying artery territory within 1 year
Measured: 12 months
embolic stroke within in the qualifying artery territory 1 year
the number of participants who suffer from embolic stroke within in the qualifying artery territory 1 year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Dec 2025
- Primary completion15 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICAS - Intracranial AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hebei Hospital, Xuanwu Xiongan Hospital, Xuanwu Chifeng Hospital, Xuanwu Jinan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309718
- Sponsor's protocol ID
- CASSISS-MPR
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 30 Dec 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Derived Pressure Ratio: a Novel Noninvasive Hemodynamic Biomarker for Stroke Risk Stratification in Intracranial Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT07309718
- Acronym / sponsor ID
- CASSISS-MPR
- Keywords
- ICAS - Intracranial Atherosclerosis, Stroke Ischemic, Hemodynamic, Pressure ratio
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Xuanwu Hebei Hospital, Xuanwu Xiongan Hospital, Xuanwu Chifeng Hospital, Xuanwu Jinan Hospital
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 Dec 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.
Intracranial atherosclerotic stenosis (ICAS) carries substantial stroke risk despite optimal medical treatment. Current risk stratification relies primarily on stenosis severity, but novel hemodynamic markers may improve prediction. In this multiple prospective registry study we aim to investigate whether regional hemodynamics, measured by a novel Magnetic resonance imaging-derived Pressure Ratio (MPR) technique, are associated with stroke risk in ICAS.
Detailed description
This study is a multicentre prospective single-arm registry study and the protocol is approved by the ethics committee at the coordinating centre and by the local institutional review board at each participating centre. This study is initiated by the investigators, with 5 participating stroke centres , and plans to recruit 400 consecutive patients who meet the inclusion and exclusion criteria. After the enrolment, all participants would be evaluated at baseline, 1 month, 6 months, and 12 months post-enrollment. All participants received standardized medical therapy, including dual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines. Multimodal imaging techniques were employed to assess hemodynamic status: luminal stenosis would be evaluated using transcranial Doppler (TCD), computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA), high-resolution MRI and phase-contrast MR angiography (PC-MRA) would be collected to calculate MPR. The primary outcomes were ischemic stroke in the qualifying artery territory or related death within 1 year. There were 5 secondary outcomes, including hemodynamic ischemic stroke in the qualifying artery territory within1 year. An independent Data and Safety Monitoring Board (DSMB) oversees the conduction, safety and efficacy of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CASSISS-MPR | – | Drug: Standardized medical therapy targeting vascular risk factors and stroke prevention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ICAS involving 50% to 99% stenosis of a major intracranial artery in the anterior circulation, including the internal carotid artery (ICA C6-C7 segment) and the middle cerebral artery M1 (MCA-M1) segment.
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years.
- Intracranial atherosclerotic stenosis ICAS involving a culprit artery in the anterior circulation.
- Intracranial arterial stenosis of 50% to 99% as measured by the WASID method using TCD, CTA, MRA, or DSA.
- Written informed consent obtained from the participant or a legal representative.
Key exclusion criteria (5 listed)
- Non-atherosclerotic intracranial lesions, including moyamoya disease, vasculitis, vascular dissection, autoimmune diseases, or congenital/genetic abnormalities.
- More than 50% stenosis of the extracranial carotid artery on the ipsilateral side.
- Large cerebral infarction involving more than one-half of the territory on DWI imaging, or a baseline modified Rankin Scale score ≥3.
- Contraindications to antiplatelet therapy or statins.
- Inability to undergo MRI due to metal implants or claustrophobia.
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 |
|---|---|---|
| Standardized medical therapy targeting vascular risk factors and stroke preventionDual antiplatelet treatment and management of vascular risk factors, in accordance with AHA/ASA guidelines | Drug | CASSISS-MPR |
Primary outcome
ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
Time frame: 12 months
the number of participants who suffer from ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment.
5 secondary outcomes
transient ischemic attack (TIA) or ischemic stroke in the qualifying artery territory within 1 year
Time frame: 12 months
TIA related to ischemia in the qualifying artery territory within 1 year
Time frame: 12 months
any stroke/TIA/ death within 1 year
Time frame: 12 months
hemodynamic ischemic stroke in the qualifying artery territory within 1 year
Time frame: 12 months
embolic stroke within in the qualifying artery territory 1 year
Time frame: 12 months
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 30 Dec 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.
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 ICAS - Intracranial Atherosclerosis and Stroke Ischemic, run by Xuanwu Hospital, Beijing 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: looking for participants now, as of the sponsor's last update on 30 Dec 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 Jichang Luo, M.D. (+86 13120136577, luojichang_dr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemic stroke in the qualifying artery territory or related death within 1 year after enrollment. (time frame: 12 months). 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 30 Dec 2025.