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

NCT ID: NCT06190314

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2024-11-30

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.

Conditions

Cerebrovascular Event; Vitamin b12; Hemorrhagic Stroke; Ischemic Stroke

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

patients with ischemic stroke

measure serum vitamin b12 levels

Measure serum vitamin b12 levels

Intervention Type: DIAGNOSTIC_TEST

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

patients with hemorrhagic stroke

measure serum vitamin b12 levels

Measure serum vitamin b12 levels

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Measure serum vitamin b12 levels

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoval Briones Jocelin Lisset

UNKNOWN

Sponsor Role: collaborator

Hirata Medina Nancy Midory

UNKNOWN

Sponsor Role: collaborator

Felix Escobedo Marisol

UNKNOWN

Sponsor Role: collaborator

Cervantes De Carlos Cereza Guadalpe

UNKNOWN

Sponsor Role: collaborator

Aceves Lozano Natalia

UNKNOWN

Sponsor Role: collaborator

Cota Andara Manuel Eduardo

UNKNOWN

Sponsor Role: collaborator

Avila Pacheco Manlio Abraham

UNKNOWN

Sponsor Role: collaborator

Rodriguez Gonzalez Alondra

UNKNOWN

Sponsor Role: collaborator

Barruquin Sandoval Claudia Pamela

UNKNOWN

Sponsor Role: collaborator

González Gómez René Ignacio

UNKNOWN

Sponsor Role: collaborator

Jaramillo Ramirez Hiram Javier.

UNKNOWN

Sponsor Role: collaborator

Hospital General de Mexicali

OTHER

Sponsor Role: lead

Responsible Party

Hiram Jaramillo Ramirez

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Mexicali

Mexicali, Estado de Baja California, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Hiram Jaramillo, MD

Role: CONTACT

grupoinvestigacionmedica@gmail.com

6861358412

Facility Contacts

Hiram Jaramillo, MD

Role: primary

grupoinvestigacionmedica@gmail.com

6861358412

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Related Links

https://pubmed.ncbi.nlm.nih.gov/30670531/

Vitamin B 12 deficiency and hyperhomocysteinaemia in outpatients with stroke or transient ischaemic attack: a cohort study at an academic medical centre

https://pubmed.ncbi.nlm.nih.gov/26846858/

Missed Ischemic Stroke Diagnosis in the Emergency Department by Emergency Medicine and Neurology Services

https://www.nature.com/articles/s41572-019-0118-8

Ischaemic stroke

https://pubmed.ncbi.nlm.nih.gov/32653056/

Stroke

https://pubmed.ncbi.nlm.nih.gov/16601863/

Homocysteine metabolism, hyperhomocysteinaemia and vascular disease: an overview

https://link.springer.com/article/10.1007/s12603-010-0280-x

Biomarkers of cobalamin (vitamin B12) deficiency and its application

https://pubmed.ncbi.nlm.nih.gov/24942828/

Guidelines for the diagnosis and treatment of cobalamin and folate disorders

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565665/

Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials

https://pubmed.ncbi.nlm.nih.gov/26182415/

Novel Stroke Therapeutics: Unraveling Stroke Pathophysiology and Its Impact on Clinical Treatments

https://pubmed.ncbi.nlm.nih.gov/9178790/

Plasma homocysteine as a risk factor for vascular disease. The European Concerted Action Project

https://www.nature.com/articles/nrdp201740

Vitamin B12 deficiency

https://pubmed.ncbi.nlm.nih.gov/16484610/

Distinguishing between stroke and mimic at the bedside: the brain attack study

https://pubmed.ncbi.nlm.nih.gov/25771069/

Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial

Other Identifiers

02-01-HGMXL/CEI/2023-23

Identifier Type: -

Identifier Source: org_study_id