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临床试验/NCT05026489
NCT05026489Unknown不适用

Prevalence of G6PD Deficiency in Cerebral Infarction Patients and the Correlation With Prognosis in Shaanxi Province

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
试验地点
1
主要终点
Prevalence of G6PD deficiency

研究概览

简要总结

Cerebral infarction brings heavy burden to patients and families with high morbidity, mortality, disability and recurrence rate. Anti-platelet aggregation therapy plays important role for secondary prevention of cerebral infarction. G6PD deficiency is a rare genetic disorder, patients with this disorder could suffer hemolysis after eating broad beans. Professor Zeng Jinsheng et al found that the hemolysis risk of G6PD deficiency patients was significantly increased when aspirin was applied in Guangdong Province. However, the prevalence of G6PD deficiency in northern China remains unknown, as well as the safety of antiplatelet therapy. To this end, 1000 patients with acute cerebral infarction will be continuously included in 30 second-level and above hospitals in 10 prefectures and cities of Shaanxi Province for observation and follow-up for 12 months, to explore the prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province, and to analyze the relationship between G6PD deficiency and the clinical characteristics and prognosis of cerebral infarction. To clarify the efficacy and safety of antiplatelet therapy for G6PD patients with cerebral infarction is of great significance for guiding the individualized treatment of cerebral infarction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • meets the diagnostic criteria of acute cerebral infarction established by Neurology Society of Chinese Medical Association, and confirmed by cranial Magnetic Resonance Imaging;
  • Time from onset to enrollment ≤14 days;
  • Volunteer to participate in the study and sign the informed consent.

排除标准

  • Silent cerebral infarction with no symptoms and signs;
  • Complicated with post-infarction hemorrhage;
  • Cerebral hernia and other complications caused by massive cerebral infarction may lead to death in acute phase;
  • Cardiogenic cerebral embolism caused by atrial fibrillation;
  • Cerebral infarction caused by tumor, vasculitis and other special reasons;
  • Complicated with serious systemic diseases, including liver and kidney insufficiency, respiratory failure, heart failure, infection, etc

结局指标

主要结局

Prevalence of G6PD deficiency

时间窗: up to 24 weeks

Prevalence of G6PD deficiency in cerebral infarction patients in Shaanxi Province

次要结局

  • National Institute of Health stroke scale(1 year)
  • All-cause mortality rate(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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