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临床试验/NCT06190314
NCT06190314招募中不适用

SERUM VITAMIN B12 LEVELS IN PATIENTS WITH HEMORRHAGIC VS ISCHEMIC CEREBROVASCULAR EVENT.

Hospital General de Mexicali1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Difference of vitamin B12 level between ischemic and hemorrhagic stroke

研究概览

简要总结

Cerebral vascular events (CVA) have a high prevalence in our environment; they are the first cause of disability and the second cause of death in the world (6.6 million deaths). 71% of all strokes worldwide correspond to the ischemic type, which is defined as an infarction in the brain, spinal cord or retina; The remaining 10-40% are hemorrhagic and are due to rupture of cerebral arteries. Until epidemiological week 35 of 2022, 34,643 cases were reported in Mexico, for this week in 2021, 26,462 cases had been reported. Baja California is among the first three places in the country with the highest number of reported cases, the majority corresponding to the male sex. The key clinical characteristic is the sudden appearance of a focal neurological deficit. Imaging studies such as head computed tomography or magnetic resonance imaging allow us to differentiate the subtype and mechanism of CVD since treatment differs markedly between CVD of ischemic origin and that of hemorrhagic origin. Vitamin B12 or cobalamin is a tetrapyrrole cofactor; One of its functions is to participate in the metabolism of homocysteine, which has been reported in various studies and it has been shown that high levels of this increase the risk of vascular diseases, such as stroke. On the other hand, vitamin B12 deficiency can lead to platelet dysfunction, causing significant bleeding. There are few protocols that have sought the direct association of cobalamin with CVD and even fewer with the hemorrhagic type. This condition is one of the main causes of admission to the Emergency Service of the General Hospital of Mexicali where they are given the necessary attention such as performing imaging studies and taking laboratory samples and based on the results the treatment to be followed is decided; However, measurements of vitamin B12 levels are not performed in this population. If the association is demonstrated, it could be implemented as a preventive measure for cerebral vascular events.

详细描述

General objective: To demonstrate if there is a difference between serum levels of vitamin B12 in patients with hemorrhagic cerebral vascular event compared to patients with ischemic cerebral vascular event.

Specific objectives

  • Describe the characteristics of the study population (sex, age, comorbidities, laboratory diagnoses)
  • Determine serum levels of vitamin B12 in patients with cerebral vascular event
  • Establish the prevalence of vitamin B12 deficiency in patients with cerebral vascular events.
  • Correlations of vitamin B12 deficiency with the severity of the disease
  • To establish whether there is a difference in serum vitamin B12 levels between patients with ischemic stroke compared to hemorrhagic stroke.
  • Determine if the degree of deficiency correlates with mortality
  • Compare vitamin B12 levels by subgroups

STUDY DESIGN This will be a prospective, observational, analytical study of patients admitted to the General Hospital of Mexicali with a diagnosis of ischemic or hemorrhagic stroke.

SOURCE FOR OBTAINING PATIENTS Patients admitted to the adult emergency department of the Mexicali General Hospital with a diagnosis of ischemic or hemorrhagic stroke are included. The information will be collected from the electronic clinical record.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age over 18 years
  • Have a diagnosis of a cerebral vascular event
  • Being a hospitalized patient at the General Hospital of Mexicali

排除标准

  • Patients without lab tests during their hospitalization
  • Patients without a cranial CT scan

结局指标

主要结局

Difference of vitamin B12 level between ischemic and hemorrhagic stroke

时间窗: November 2023 - November 2024

Demonstrate if there is a difference between serum levels of vitamin B12 in patients with hemorrhagic cerebral vascular event compared to patients with ischemic cerebral vascular event.

次要结局

  • Population characteristics(November 2023 - November 2024)
  • Vitamin B12 defficiency in patients with stroke(November 2023 - November 2024)
  • Mortality and vitamin B 12 deficiency in this specific population(November 2023 - November 2024)
  • Levels of B12 vitamin and severity of stroke(November 2023 - November 2024)

研究者

发起方
Hospital General de Mexicali
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hiram Jaramillo Ramirez

Serum Vitamin B12 levels in patients with hemorrhagic vs ischemic cerebrovascular event

Hospital General de Mexicali

研究点 (1)

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