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Идёт набор NCT06584565

A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke

— Наблюдательное Ischemic Stroke, Acute

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: microbiome; metabolomics; proteomics.
Кому может быть актуально
Состояния в реестре: Ischemic Stroke, Acute. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

Through a multicenter prospective AIS cohort study, we analyze the potential association of human proteome, microbiome and metabolome alterations with AIS prognosis, searching for key proteins, differential organisms and metabolites, combining experimental data at multiple molecular levels with computational models, and establishing early prediction models through machine learning-based prediction algorithms. While closely tracking the recurrence of stroke in AIS patients, we evaluate the predictive value of human proteome, microbiome and metabolites for stroke recurrence through a nested case-control study, which provides key reference information for exploring the unknown residual risk of AIS recurrence.

Подробное описание

Currently, the burden of brain vascular disease in China is the highest in the world, and among them, the incidence rate of acute ischemic stroke (AIS) is high, the recurrence rate is high, the disability rate is high, the mortality rate is high, and the social burden is heavy. With the increasing number of AIS patients, how to effectively prevent and treat them is a huge challenge facing us. The occurrence and development of AIS are caused by the joint action of multiple risk factors and mutual influence, and single technical means are difficult to deeply explore its complex mechanism. Therefore, building a risk prediction model for poor prognosis and recurrence based on multi-omics technology and layering risk factors for patients are the important research directions for the future. This study aims to establish a multi-center cohort by collecting fecal and blood samples from AIS patients and conducting proteomic, microbial and metabolomic detection. It records the prognosis and recurrence events and uses cross-omics analysis technology to explore the multi-omics network molecular mechanism and screen for new intervention targets. It establishes an early prediction model and explores the stroke secondary prevention strategy based on multi-omics data.

Вмешательства

  • Другое microbiome; metabolomics; proteomics
    post-stroke change of microbiome; metabolomics; proteomics

Первичные конечные точки

  • Incidence of new cardiovascular events and death [Срок оценки: within 12 months after onset]
Вторичные конечные точки (10)
  • Brain Injury Conditions [Срок оценки: 3, 12 months after ischemic stroke]
  • Small Vessel Disease Burden [Срок оценки: 3, 12 months after ischemic stroke]
  • Cerebrovascular Pathology [Срок оценки: 3, 12 months after ischemic stroke]
  • Modified Rankin Scale ( mRS ) score [Срок оценки: 7 day and 3, 12 months after ischemic stroke]
  • National Institutes of Health Stroke Scale ( NIHSS ) score [Срок оценки: 7 day and 3, 12 months after ischemic stroke]
  • Activity of Daily Living Scale ( ADL ) score [Срок оценки: 7 day and 3, 12 months after ischemic stroke]
  • Mini-mental State Examination ( MMSE ) score [Срок оценки: 3, 12 months after ischemic stroke]
  • Montreal Cognitive Assessment ( MOCA ) score [Срок оценки: 3, 12 months after ischemic stroke]
  • Hamilton Depression Scale ( HAMD ) score [Срок оценки: 3, 12 months after ischemic stroke]
  • Hamilton Anxiety Scale ( HAMA ) score [Срок оценки: 3, 12 months after ischemic stroke]

Критерии участия

Критерии включения

  • Meet the diagnostic criteria of AIS according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018
  • Aged 18 to 75 years old
  • Stroke within 7 days of onset
  • Sign informed consent, provide relevant medical history information and provide biological specimens

Критерии исключения

  • Severe impairment of consciousness (awareness score of NIHSS>1)
  • History of stroke within 12 months
  • Severe systemic disease including malignancy
  • ALT or AST> 2 times the upper limit of normal or severe liver disease
  • creatinine > 1.5 times the upper limit of normal or severe kidney disease
  • History of long-term drinking, drug use, and chemical poisoning (e.g., pesticide poisoning); Note: Long-term alcohol consumption, usually more than 5 years, over 40 g/day of alcohol for men and 20 g/day for women, or a history of heavy alcohol consumption within 2 weeks, over 80 g/day of alcohol
  • History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease or confirmed in the hospital
  • Unable to collect a stool specimen within 4 days of admission
  • Assessed to be unsuitable for participation in this study by the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Nanfang Hospital,Southern Medical University — Гуанчжоу

Идентификаторы

NCT: NCT06584565 · NFEC-2024-150

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗