Cerebrovascular DiseaseNCT06925178
Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease
An observational study of Cerebrovascular Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The aim of this study is to establish a multi-center and multi-modality imaging standard cohort of cerebrovascular disease, analyze the potential mechanisms affecting the prognosis of cerebrovascular disease based on a variety of imaging methods, and explore potential therapeutic targets. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Disease
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Sep 2027
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-80 years old with acute cerebrovascular disease (hemorrhagic or ischemic stroke) within 7 days of onset； healthy adults.
Who may be able to join
- Age between 18 and 80 years old;
- Onset of symptoms within 7 days;
- Clinical diagnosis of cerebrovascular disease (ischemic stroke or hemorrhagic stroke) confirmed by head imaging (CT or MRI);
- Signed informed consent form.
Who cannot join
- Diagnosed with non-cerebrovascular diseases (such as central nervous system infections, epilepsy, and metabolic encephalopathy);
- Patients with contraindications to multimodal CT or MRI, functional near-infrared imaging, or those who cannot cooperate to complete the relevant examinations;
- Patients with a life expectancy of less than 3 months or those who cannot complete the study follow-up due to other reasons.
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
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
wenjie wang, 18843113250
About this study
The aim of this study is to establish a multi-center and multi-modality imaging standard cohort of cerebrovascular disease, analyze the potential mechanisms affecting the prognosis of cerebrovascular disease based on a variety of imaging methods, and explore potential therapeutic targets.
Read the detailed description
Cerebrovascular diseases are major diseases that pose a serious threat to human health and life, and have become the leading cause of death from disease among Chinese residents. Despite the best medical or surgical treatment options, many patients still suffer from functional disabilities, imposing a heavy burden on families and society. Identifying the complex and delicate changes in brain neural activity, blood flow, oxygenation, and metabolism following the occurrence of cerebrovascular diseases can not only explore the potential mechanisms underlying poor functional prognosis, but also provide a scientific basis for targeted treatment strategies. This study is a consecutive, multicenter, prospective registration study that recruits approximately 800 patients with cerebrovascular diseases (both hemorrhagic and ischemic stroke) aged 18-80 years within 7 days of onset. The study collects baseline information and imaging data including head CT, MRI, TCD, fNIRS, and ophthalmic testing. The primary endpoint event was functional outcome 3 months (mRS score). Secondary outcomes were in-hospital complications (including stroke progression, recurrence, and mortality), cognitive disorder, functional outcomes, recurrent stroke, new vascular events, and all-cause death at 3, 6 and 12 months .
- Conditions
- Cerebrovascular Disease
- Keywords
- stroke, progonosis, imaging, cognitive disorder
- Medical subject headings
- Cerebrovascular Disorders, Stroke, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of unfavorable functional outcome
Unfavorable functional outcome is defined as mRS Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.
Measured: 3 month after enrollment
Secondary outcomes (6)
The incidence of in-hospital complications
In-hospital complications (including stroke progression, recurrence, and mortality).
Measured: duration of hospital stay（about 1 week）
The incidence of unfavorable functional outcome
Unfavorable functional outcome is defined as the modified Rankin Scale (mRS) Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.
Measured: 6 and 12 months after enrollment
The incidence of new vascular events
Including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death.
Measured: 3, 6 and 12 months after enrollment
The incidence of recurrent stroke
Stroke recurrence is defined as a new focal neurological impairment that was confirmed by neuroimaging, including both ischemic stroke and hemorrhagic stroke.
Measured: 3, 6 and 12 months after enrollment
The incidence of all-cause death
An all-cause death is defined as a death from any cause.
Measured: 3, 6 and 12 months after enrollment
The incidence of Cognitive impairment
Cognitive impairment is assessed using the MMSE and MOCA scales, with scores below 27 on the MMSE or below 26 on the MOCA indicating the presence of cognitive impairment.
Measured: 3, 6 and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Jan 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zi-Xiao Li, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925178
- Sponsor's protocol ID
- HX-B-2024061
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 13 Apr 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 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT06925178
- Acronym / sponsor ID
- HX-B-2024061
- Conditions
- Cerebrovascular Disease
- Keywords
- stroke, progonosis, imaging, cognitive disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Apr 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 aim of this study is to establish a multi-center and multi-modality imaging standard cohort of cerebrovascular disease, analyze the potential mechanisms affecting the prognosis of cerebrovascular disease based on a variety of imaging methods, and explore potential therapeutic targets.
Detailed description
Cerebrovascular diseases are major diseases that pose a serious threat to human health and life, and have become the leading cause of death from disease among Chinese residents. Despite the best medical or surgical treatment options, many patients still suffer from functional disabilities, imposing a heavy burden on families and society. Identifying the complex and delicate changes in brain neural activity, blood flow, oxygenation, and metabolism following the occurrence of cerebrovascular diseases can not only explore the potential mechanisms underlying poor functional prognosis, but also provide a scientific basis for targeted treatment strategies. This study is a consecutive, multicenter, prospective registration study that recruits approximately 800 patients with cerebrovascular diseases (both hemorrhagic and ischemic stroke) aged 18-80 years within 7 days of onset. The study collects baseline information and imaging data including head CT, MRI, TCD, fNIRS, and ophthalmic testing. The primary endpoint event was functional outcome 3 months (mRS score). Secondary outcomes were in-hospital complications (including stroke progression, recurrence, and mortality), cognitive disorder, functional outcomes, recurrent stroke, new vascular events, and all-cause death at 3, 6 and 12 months .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-80 years old with acute cerebrovascular disease (hemorrhagic or ischemic stroke) within 7 days of onset； healthy adults.
Key inclusion criteria (4 listed)
- Age between 18 and 80 years old;
- Onset of symptoms within 7 days;
- Clinical diagnosis of cerebrovascular disease (ischemic stroke or hemorrhagic stroke) confirmed by head imaging (CT or MRI);
- Signed informed consent form.
Key exclusion criteria (3 listed)
- Diagnosed with non-cerebrovascular diseases (such as central nervous system infections, epilepsy, and metabolic encephalopathy);
- Patients with contraindications to multimodal CT or MRI, functional near-infrared imaging, or those who cannot cooperate to complete the relevant examinations;
- Patients with a life expectancy of less than 3 months or those who cannot complete the study follow-up due to other reasons.
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
The incidence of unfavorable functional outcome
Time frame: 3 month after enrollment
Unfavorable functional outcome is defined as mRS Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.
6 secondary outcomes
The incidence of in-hospital complications
Time frame: duration of hospital stay（about 1 week）
The incidence of unfavorable functional outcome
Time frame: 6 and 12 months after enrollment
The incidence of new vascular events
Time frame: 3, 6 and 12 months after enrollment
The incidence of recurrent stroke
Time frame: 3, 6 and 12 months after enrollment
The incidence of all-cause death
Time frame: 3, 6 and 12 months after enrollment
The incidence of Cognitive impairment
Time frame: 3, 6 and 12 months after enrollment
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 Apr 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 Cerebrovascular Disease, 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 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 13 Apr 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 zixiao Li, PhD (00861067013383, lizixiao2008@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of unfavorable functional outcome (time frame: 3 month after enrollment). 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 Apr 2025.