Thrombus, BrainTitanNCT05663281
Thrombus Imaging and Treatment Analytics in Neurology
An observational study of Thrombus, Brain and Thrombosis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to investigate the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombus, Brain, Thrombosis
- What is being tested?
- thrombus imaging appearance
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who are confirmed to have extracranial and/or intracranial artery occlusion
Who may be able to join
- Age ≥ 18 years
- Extracranial and/or intracranial artery occlusion confirmed by angiography
- Available for magnetic resonance high-resolution vessel wall imaging
- Written informed consent obtained
Who cannot join
- Extracranial and/or intracranial artery mild to moderate stenosis
- Pregnant women
- Restenosis or occlusion after artery stenting placement
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
In the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to investigate the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment.
Read the detailed description
Cerebral ischemic stroke resulting from thrombosis causes high disability and mortality. There are few biomarkers to evaluate arterial thrombophilia until now. Previous studies have demonstrated that atherosclerotic plaque rupture and erosion are major etiologies initiating thrombosis. Based on previous works targeting the role of plaque and blood flow in cerebrovascular disease, in the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to explore the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment. The study's objective was to solve the challenges in the mechanism of thrombus features and the outcome of recanalization therapy, thus helping improve the primary and secondary prevention of cerebrovascular disease.
- Conditions
- Thrombus, Brain, Thrombosis
- Being tested
- thrombus imaging appearance
- Keywords
- Thrombus, Neuroimaging, High-resolution vessel wall imaging, Cerebral ischemia, Cerebral artery
- Medical subject headings
- Intracranial Thrombosis, Thrombosis, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombus imaging appearanceDiagnostic test
Imaging appearance of intracranial and/or extracranial arterial thrombus
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful Recanalization
Antegrade blood flow through the recanalized portion was assessed by thrombolysis in myocardial infarction (TIMI) score or thrombolysis in cerebral infarction (TICI) score. TIMI≥2 or TICI≥2b was defined as successful recanalization.
Measured: 1-3 Years
Ischemic Stroke Occurrence
Ischemic stroke occurrence during follow-up period which was confirmed by neuroimaging
Measured: 1-3 Years
Secondary outcomes (1)
Number of Participants with Adverse Events
hemorrhagic or ischemic stroke after recanalization treatment
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 posted23 Dec 2022
- Study start15 Dec 2022
- 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 Thrombus, BrainStudies 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
- 100 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663281
- Sponsor's protocol ID
- 301Titan
- Acronym
- Titan
- Status last verified
- Jun 2024
- First submitted
- 15 Dec 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Thrombus Imaging and Treatment Analytics in Neurology
- ClinicalTrials.gov ID
- NCT05663281
- Acronym / sponsor ID
- Titan / 301Titan
- Conditions
- Thrombus, Brain, Thrombosis
- Keywords
- Thrombus, Neuroimaging, High-resolution vessel wall imaging, Cerebral ischemia, Cerebral artery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Dec 2022 (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.
In the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to investigate the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment.
Detailed description
Cerebral ischemic stroke resulting from thrombosis causes high disability and mortality. There are few biomarkers to evaluate arterial thrombophilia until now. Previous studies have demonstrated that atherosclerotic plaque rupture and erosion are major etiologies initiating thrombosis. Based on previous works targeting the role of plaque and blood flow in cerebrovascular disease, in the present study, the investigators use high-resolution MR vessel wall imaging, and select patients with cerebral and cervical artery occlusion to explore the relationship between the imaging appearance of thrombus and the various outcome of recanalization treatment. The study's objective was to solve the challenges in the mechanism of thrombus features and the outcome of recanalization therapy, thus helping improve the primary and secondary prevention of cerebrovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who are confirmed to have extracranial and/or intracranial artery occlusion
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Extracranial and/or intracranial artery occlusion confirmed by angiography
- Available for magnetic resonance high-resolution vessel wall imaging
- Written informed consent obtained
Key exclusion criteria (3 listed)
- Extracranial and/or intracranial artery mild to moderate stenosis
- Pregnant women
- Restenosis or occlusion after artery stenting placement
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 |
|---|---|---|
| thrombus imaging appearanceImaging appearance of intracranial and/or extracranial arterial thrombus | Diagnostic test | – |
Primary outcome
Rate of Successful Recanalization
Time frame: 1-3 Years
Antegrade blood flow through the recanalized portion was assessed by thrombolysis in myocardial infarction (TIMI) score or thrombolysis in cerebral infarction (TICI) score. TIMI≥2 or TICI≥2b was defined as successful recanalization.
Ischemic Stroke Occurrence
Time frame: 1-3 Years
Ischemic stroke occurrence during follow-up period which was confirmed by neuroimaging
1 secondary outcome
Number of Participants with Adverse Events
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.
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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 Thrombus, Brain and Thrombosis, 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, M.D. (+8615903562929, 330322990@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful Recanalization (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.