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Идёт набор NCT04847752

Study of Predictive Factors Related to Prognosis of Patients With Ischemic Stroke Due to Large-artery Atherosclerosis

Наблюдательное Ischemic Stroke Large-Artery Atherosclerosis (Embolus/Thrombosis)

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: carotid artery stenting, carotid endarterectomy, Aspirin, Clopidogrel.
Кому может быть актуально
Состояния в реестре: Ischemic Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis). Базовые параметры: до 80 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Prospective Observational Cohort Study of Predictive Factors Related to Prognosis of In-hosiptal Patients With Ischemic Stroke Due to Large-artery Atherosclerosis

Обзор

This is a single-center prospective cohort study of predictive factors related to prognosis of ischemic stroke due to large-artery atherosclerosis. From March 1, 2021 to December 31, 2026, 1000 patients with ischemic stroke due to large-artery atherosclerosis who are admitted to the Department of Neurology or Neurosurgery, Tongji Hospital are going to be recruited. Detailed clinical data in emergency room and in-hospital will be obtained from the medical record reviews, and the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) score will be done by certified neurologists to assess the severity of the disease in acute stage and treatment outcome during the follow-up. All cases will undergo routine blood tests, brain magnetic resonance imaging (MRI) and cerebral vascular examination, such as TCD, CTA, HRMR or DSA. The investigators will analyze the in-hospital factors that could predict the outcome to provide more evidence-based suggestions in the treatment and prognosis of atherosclerotic ischemic cerebrovascular disease.

Подробное описание

The detaited information about this trial is described below

1. Quality assurance: The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement. 2. Data check: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. 3. Source data verification: Medical records, electronic case report forms, and imaging would be processed by certified neurologists. 4. Data included:

4.1 Baseline Variables: NIHSS and mRS scores before ischemic stroke 4.2 In-hospital Variables: 4.2.1 Main symptoms(1=facial paralysis 2=limb weakness 3=limb numbness 4=facial numbness 5=lalopathy 6=ataxia 7=dysphagia 8=bulbar paralysis 9=dizziness 10=nausea and vomit 11=vision disorder 12=confusion 13=headache 14=unconsciousness 15=others) NIHSS and mRS scores after admission 4.2.2 Brain CT and ASPECT scores 4.2.3 DWI 4.2.4 CTA, MRA, DSA, carotid artery ultrasound andTCD to evaluate the stenosis degree of large vessels 4.2.5 HRMR to evaluate the changes of the plaque of intracranial stenosis 4.2.6 Blood routine tests 4.2.7 HbALc and FBG 4.2.8 LDL HDL ApoA1 and ApoB 4.2.9 Cardiac TnI and NT-proBNP 4.2.10 Proteomic analysis of fresh plasma 4.2.11 Histopathological tissues and transcriptomics of CEA 5. Standard Operating Procedures 5.1 Patient recruitment: From March 1, 2021 to December 31, 2026, 1000 patients with ischemic stroke due to large-artery atherosclerosis who are admitted to the Department of Neurology and Neurosurgery, Tongji Hospital are going to be recruited 5.2 Data collection: Detailed clinical data in emergency room and in-hospital will be obtained from the medical record reviews, and the National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (mRS) score will be done by certified neurologists to assess the severity of the disease in acute stage and clinical outcome during the follow-up. All cases would undergo routine blood tests, brain magnetic resonance imaging (MRI) and cerebral vascular examination, such as TCD, CTA, HRMR or DSA.

5.3 Data management, The research data is reviewed by an Independent Research Panel.

5.4 Data analysis: Biostatisticians from the Department of Neurology, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology will conduct statistical analysis 6. Sample size assessment: About 1000 cases. 7. Plan for missing data: The number of lost cases will be treated as the deleted value and the lost rate will be indicated. Complete sample intentionality analysis and intent-to-treat (ITT) analysis would be performed on the end points. During the analysis, if there is a statistical difference in the results, the number of participants lost in the exposed group will be deleted, and the number of participants lost to in the non-exposed group will be added. If there is still a statistical difference in the results, the loss of follow-up will not have an impact on the analysis results of this group. 8. Statistical analysis: All statistical data would be analyzed by the SPSS Software 24.0 version. Continuous variables would be reported as median (range, minimum-maximum), which would be compared by Mann-Whitney test, and categorical data would be represented as percentages and frequencies, which would be compared by the two-tailed Fisher's exact test or one-way ANOVA. P\<0.05 would be considered statistically significant.

Вмешательства

  • Процедура carotid artery stenting
    common treatments for carotid artery stenosis
  • Процедура carotid endarterectomy
    common treatments for carotid artery stenosis
  • Препарат Aspirin
    the dosage and duration
  • Препарат Clopidogrel
    the dosage and duration
  • Препарат Anticoagulant
    the dosage and duration
  • Препарат Statin
    the dosage and duration
  • Препарат PCSK9 inhibitor
    the dosage and duration

Первичные конечные точки

  • all-cause mortality [Срок оценки: 3-6 months after onset.]
  • Stroke of any kind [Срок оценки: 3-6 months after onset.]
Вторичные конечные точки (3)
  • Rehospitalization [Срок оценки: 1 month to 24 months after onset.]
  • National Institute of Health stroke scale (NIHSS score) [Срок оценки: 1 month to 24 months after onset.]
  • modified Ranking score (mRS) [Срок оценки: 1 month to 24 months after onset.]

Критерии участия

Критерии включения

  • Ischemic stroke due to large-artery atherosclerosis has been proved by clinical symptoms and imaging examinations.
  • Symptomatic superior arch stenosis >50%
  • Asymptomatic superior arch stenosis was >70%
  • written informed consent was obtained from patients or their surrogates before enrollment.

Критерии исключения

  • Brain CT or MRI showing cerebral hemorrhage (excluded ischemic stroke with hemorrhage transformation)
  • With severe systemic disease, are expected to survive < 3 months
  • Patients will not able to provide continuous follow-up information

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT04847752 · TJID-20210404TDS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗