Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190314
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-19
Brief Title:
SERUM VITAMIN B12 LEVELS IN PATIENTS WITH HEMORRHAGIC VS ISCHEMIC CEREBROVASCULAR EVENT
Sponsor:
Hospital General de Mexicali
Organization:
Hospital General de Mexicali
Study Overview
Official Title:
SERUM VITAMIN B12 LEVELS IN PATIENTS WITH HEMORRHAGIC VS ISCHEMIC CEREBROVASCULAR EVENT
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ViBEVC
Brief Summary:
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 66 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 34643 cases were reported in Mexico for this week in 2021 26462 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
Detailed Description:
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
Non-probability sampling for convenience Select all patients who arrive at the hospital who meet inclusion criteria and do not have any exclusion or elimination criteria
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
Non-probability sampling for convenience Select all patients who arrive at the hospital who meet inclusion criteria and do not have any exclusion or elimination criteria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None