Clinical trial NCT06925178: Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease
Official title: Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Disease
Keywords: stroke
progonosis
imaging
cognitive disorder
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-80 years old with acute cerebrovascular disease (hemorrhagic or ischemic stroke) within 7 days of onset； healthy adults.

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of unfavorable functional outcome
timeFrame: 3 month after enrollment
Secondary outcomes:
measure: The incidence of in-hospital complications
timeFrame: duration of hospital stay（about 1 week）
measure: The incidence of unfavorable functional outcome
timeFrame: 6 and 12 months after enrollment
measure: The incidence of new vascular events
timeFrame: 3, 6 and 12 months after enrollment
measure: The incidence of recurrent stroke
timeFrame: 3, 6 and 12 months after enrollment
measure: The incidence of all-cause death
timeFrame: 3, 6 and 12 months after enrollment
measure: The incidence of Cognitive impairment
timeFrame: 3, 6 and 12 months after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: