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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06190314
Acronym
ViBEVC
Enrollment
100
Registered
2024-01-05
Start date
2023-11-13
Completion date
2024-11-30
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Event, Hemorrhagic Stroke, Ischemic Stroke, Vitamin b12

Keywords

Stroke, Hemorrhagic, B12, Ischemic

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 (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.

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.

Interventions

DIAGNOSTIC_TESTMeasure serum vitamin b12 levels

Measure the vitamin b-12 levels in patients that are admitted for stroke of any kind

Sponsors

Sandoval Briones Jocelin Lisset
CollaboratorUNKNOWN
Hirata Medina Nancy Midory
CollaboratorUNKNOWN
Felix Escobedo Marisol
CollaboratorUNKNOWN
Cervantes De Carlos Cereza Guadalpe
CollaboratorUNKNOWN
Aceves Lozano Natalia
CollaboratorUNKNOWN
Cota Andara Manuel Eduardo
CollaboratorUNKNOWN
Avila Pacheco Manlio Abraham
CollaboratorUNKNOWN
Rodriguez Gonzalez Alondra
CollaboratorUNKNOWN
Barruquin Sandoval Claudia Pamela
CollaboratorUNKNOWN
González Gómez René Ignacio
CollaboratorUNKNOWN
Jaramillo Ramirez Hiram Javier.
CollaboratorUNKNOWN
Hospital General de Mexicali
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Difference of vitamin B12 level between ischemic and hemorrhagic strokeNovember 2023 - November 2024Demonstrate 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.

Secondary

MeasureTime frameDescription
Vitamin B12 defficiency in patients with strokeNovember 2023 - November 2024Vitamin B12 defficiency in patients with any kind of stroke
Population characteristicsNovember 2023 - November 2024Determine if variables like sex, age, comorbilities and lab tests have a correlation between stroke and Vitamin B12 levels
Mortality and vitamin B 12 deficiency in this specific populationNovember 2023 - November 2024Analize the levels of vitamin B12 and the in-hospital mortality in this population
Levels of B12 vitamin and severity of strokeNovember 2023 - November 2024Analize if there is a significant difference between the levels of B12 and the severity of stroke

Countries

Mexico

Contacts

Primary ContactHiram Jaramillo, MD
grupoinvestigacionmedica@gmail.com6861358412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026