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Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease

Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06925178
Enrollment
800
Registered
2025-04-13
Start date
2025-01-01
Completion date
2027-09-30
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disease

Keywords

stroke, progonosis, imaging, cognitive disorder

Brief 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.

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 .

Interventions

None listed

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of unfavorable functional outcome3 month after enrollmentUnfavorable 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.

Secondary

MeasureTime frameDescription
The incidence of unfavorable functional outcome6 and 12 months after enrollmentUnfavorable 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.
The incidence of new vascular events3, 6 and 12 months after enrollmentIncluding ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death.
The incidence of in-hospital complicationsduration of hospital stay(about 1 week)In-hospital complications (including stroke progression, recurrence, and mortality).
The incidence of all-cause death3, 6 and 12 months after enrollmentAn all-cause death is defined as a death from any cause.
The incidence of Cognitive impairment3, 6 and 12 months after enrollmentCognitive 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.
The incidence of recurrent stroke3, 6 and 12 months after enrollmentStroke recurrence is defined as a new focal neurological impairment that was confirmed by neuroimaging, including both ischemic stroke and hemorrhagic stroke.

Countries

China

Contacts

Primary Contactzixiao Li, PhD
lizixiao2008@hotmail.com00861067013383
Backup ContactWENJIE WANG, PhD
wangwenjie1129@163.com18843113250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026