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Recruiting NCT06925178

Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease

Observational Cerebrovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cerebrovascular Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 .

Primary outcome measures

  • The incidence of unfavorable functional outcome [Time frame: 3 month after enrollment]
Secondary outcome measures (6)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06925178 · HX-B-2024061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗