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NCT Number: NCT06925178

Multi-Modality Imaging Standard Cohort Of Cerebrovascular Disease

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

wenjie wang

CONTACT

18843113250

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. The incidence of in-hospital complications

    Time frame: duration of hospital stay(about 1 week)

    In-hospital complications (including stroke progression, recurrence, and mortality).

  2. The incidence of unfavorable functional outcome

    Time frame: 6 and 12 months after enrollment

    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.

  3. The incidence of new vascular events

    Time frame: 3, 6 and 12 months after enrollment

    Including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death.

  4. The incidence of recurrent stroke

    Time frame: 3, 6 and 12 months after enrollment

    Stroke recurrence is defined as a new focal neurological impairment that was confirmed by neuroimaging, including both ischemic stroke and hemorrhagic stroke.

  5. The incidence of all-cause death

    Time frame: 3, 6 and 12 months after enrollment

    An all-cause death is defined as a death from any cause.

  6. The incidence of Cognitive impairment

    Time frame: 3, 6 and 12 months after enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

WENJIE WANG, PhD

CONTACT

[email protected]

18843113250

zixiao Li, PhD

CONTACT

[email protected]

00861067013383

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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