ICAS - Intracranial AtherosclerosisNCT05677607
Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease
An observational study of ICAS - Intracranial Atherosclerosis and Cerebral Small Vessel Diseases, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- ICAS - Intracranial Atherosclerosis, Cerebral Small Vessel Diseases
- What is being tested?
- Magnetic resonance imaging
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2027
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with at least on intracranial artery ≥ 50% atherosclerotic stenosis.
Who may be able to join
- Age ≥ 18 years
- At least one intracranial artery ≥ 50% atherosclerotic stenosis
- Modified Rankin Scale < 2
- Mini-mental State Examination > 24
Who cannot join
- Concurrent ipsilateral extracranial artery ≥ 50% stenosis
- Pregnant women
- Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jinhao Lyu, MD, 330322990@qq.com
About this study
The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.
Read the detailed description
Cerebrovascular disease is the most common cause of death worldwide. There is a close link in structure and function between the intracranial large arteries and cerebral small vessels. Moreover, growing evidences have demonstrated that large artery atherosclerosis often coexists with small vessel disease, which may deteriorate the clinical outcomes of stroke and dementia. The mutual feedback mechanism between them is not fully understood. The present study focuses on the mechanism of mutual feedback between large artery atherosclerosis and cerebral small vessel disease by using magnetic resonance imaging. The study may provide biomarkers for the early prevention and treatment of cerebrovascular disease.
- Being tested
- Magnetic resonance imaging
- Keywords
- Intracranial atherosclerosis, Cerebral small vessel disease, Feedback mechanism, Multimodal MRI
- Medical subject headings
- Intracranial Arteriosclerosis, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Imaging diagnostics mainly based on Magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial atherosclerosis and small vessel disease | Patients diagnosed with intracranial large artery atherosclerosis and cerebral small vessel disease based on imaging screening. Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression in total cerebral small vessel disease burden
Total cerebral small vessel disease burden is assessed according to a sum of scores of white matter hyperintensity, cerebral microbleeds, lacunes and enlarged perivasular spaces on magnetic resonance imaging sequences.
Measured: 1-3 YEARS
Frequency of stroke recurrence
The percentage of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the targeted stenotic vessel.
Measured: 1-3 YEARS
Secondary outcomes (1)
Frequency of stroke of asymptomatic participants
The percentage of asymptomatic participants who suffer from stroke after enrollment in the territory of the targeted stenotic vessel.
Measured: 1-3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 Chinese PLA General 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinhao Lyu, Chinese PLA General Hospital
- Investigators
- Jinhao Lyu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677607
- Sponsor's protocol ID
- 301Brainmax
- Status last verified
- Jun 2024
- First submitted
- 19 Dec 2022
- Last updated
- 3 Jul 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT05677607
- Acronym / sponsor ID
- 301Brainmax
- Keywords
- Intracranial atherosclerosis, Cerebral small vessel disease, Feedback mechanism, Multimodal MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jan 2023 (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 present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.
Detailed description
Cerebrovascular disease is the most common cause of death worldwide. There is a close link in structure and function between the intracranial large arteries and cerebral small vessels. Moreover, growing evidences have demonstrated that large artery atherosclerosis often coexists with small vessel disease, which may deteriorate the clinical outcomes of stroke and dementia. The mutual feedback mechanism between them is not fully understood. The present study focuses on the mechanism of mutual feedback between large artery atherosclerosis and cerebral small vessel disease by using magnetic resonance imaging. The study may provide biomarkers for the early prevention and treatment of cerebrovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial atherosclerosis and small vessel disease | – | Diagnostic Test: Magnetic resonance imagingPatients diagnosed with intracranial large artery atherosclerosis and cerebral small vessel disease based on imaging screening. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with at least on intracranial artery ≥ 50% atherosclerotic stenosis.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- At least one intracranial artery ≥ 50% atherosclerotic stenosis
- Modified Rankin Scale < 2
- Mini-mental State Examination > 24
Key exclusion criteria (3 listed)
- Concurrent ipsilateral extracranial artery ≥ 50% stenosis
- Pregnant women
- Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)
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 |
|---|---|---|
| Magnetic resonance imagingImaging diagnostics mainly based on Magnetic resonance imaging. | Diagnostic test | Intracranial atherosclerosis and small vessel disease |
Primary outcome
Progression in total cerebral small vessel disease burden
Time frame: 1-3 YEARS
Total cerebral small vessel disease burden is assessed according to a sum of scores of white matter hyperintensity, cerebral microbleeds, lacunes and enlarged perivasular spaces on magnetic resonance imaging sequences.
Frequency of stroke recurrence
Time frame: 1-3 YEARS
The percentage of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the targeted stenotic vessel.
1 secondary outcome
Frequency of stroke of asymptomatic participants
Time frame: 1-3 YEARS
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 3 Jul 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.
Jinhao Lyu principal investigator
Chinese PLA General 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 ICAS - Intracranial Atherosclerosis and Cerebral Small Vessel Diseases, run by Chinese PLA General 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 3 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 3 Jul 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?
Contact Jinhao Lyu (+8615903562929, 330322990@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression in total cerebral small vessel disease burden (time frame: 1-3 YEARS). 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 3 Jul 2024.