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

NCT06190314 | Unknown DMC

• 1 other identifier: 02-01-HGMXL/CEI/2023-23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Event; Vitamin b12; Hemorrhagic Stroke; Ischemic Stroke

Keywords

Stroke; Hemorrhagic; B12; Ischemic

Outcome Measures

Primary Outcomes (1)

• Difference of vitamin B12 level between ischemic and hemorrhagic stroke

  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.

  November 2023 - November 2024

Secondary Outcomes (4)

• Vitamin B12 defficiency in patients with stroke

  November 2023 - November 2024

• Population characteristics

  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

Study Arms (2)

patients with ischemic stroke

measure serum vitamin b12 levels

Diagnostic Test: Measure serum vitamin b12 levels

patients with hemorrhagic stroke

measure serum vitamin b12 levels

Diagnostic Test: Measure serum vitamin b12 levels

Interventions

Measure serum vitamin b12 levels DIAGNOSTIC_TEST

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

patients with hemorrhagic stroke; patients with ischemic stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Select all patients who arrive at the hospital who meet inclusion criteria and do not have any exclusion or elimination criteria.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

General Hospital of Mexicali

Mexicali, Estado de Baja California, 21000, Mexico

RECRUITING

Related Publications (18)

• Ahmed S, Bogiatzi C, Hackam DG, Rutledge AC, Sposato LA, Khaw A, Mandzia J, Azarpazhoo MR, Hachinski V, Spence JD. Vitamin B 12 deficiency and hyperhomocysteinaemia in outpatients with stroke or transient ischaemic attack: a cohort study at an academic medical centre. BMJ Open. 2019 Jan 21;9(1):e026564. doi: 10.1136/bmjopen-2018-026564.

  PMID: 30670531 BACKGROUND

• Arch AE, Weisman DC, Coca S, Nystrom KV, Wira CR 3rd, Schindler JL. Missed Ischemic Stroke Diagnosis in the Emergency Department by Emergency Medicine and Neurology Services. Stroke. 2016 Mar;47(3):668-73. doi: 10.1161/STROKEAHA.115.010613. Epub 2016 Feb 4.

  PMID: 26846858 BACKGROUND

• Bick RL. Platelet function defects associated with hemorrhage or thrombosis. Med Clin North Am. 1994 May;78(3):577-607. doi: 10.1016/s0025-7125(16)30148-1.

  PMID: 8170260 BACKGROUND

• Bjorklund G, Peana M, Dadar M, Lozynska I, Chirumbolo S, Lysiuk R, Lenchyk L, Upyr T, Severin B. The role of B vitamins in stroke prevention. Crit Rev Food Sci Nutr. 2022;62(20):5462-5475. doi: 10.1080/10408398.2021.1885341. Epub 2021 Mar 16.

  PMID: 33724098 BACKGROUND

• Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.

  PMID: 31601801 BACKGROUND

• Campbell BCV, Khatri P. Stroke. Lancet. 2020 Jul 11;396(10244):129-142. doi: 10.1016/S0140-6736(20)31179-X.

  PMID: 32653056 BACKGROUND

• Castro R, Rivera I, Blom HJ, Jakobs C, Tavares de Almeida I. Homocysteine metabolism, hyperhomocysteinaemia and vascular disease: an overview. J Inherit Metab Dis. 2006 Feb;29(1):3-20. doi: 10.1007/s10545-006-0106-5.

  PMID: 16601863 BACKGROUND

• Chatthanawaree W. Biomarkers of cobalamin (vitamin B12) deficiency and its application. J Nutr Health Aging. 2011 Mar;15(3):227-31. doi: 10.1007/s12603-010-0280-x.

  PMID: 21369672 BACKGROUND

• Clarke R, Halsey J, Lewington S, Lonn E, Armitage J, Manson JE, Bonaa KH, Spence JD, Nygard O, Jamison R, Gaziano JM, Guarino P, Bennett D, Mir F, Peto R, Collins R; B-Vitamin Treatment Trialists' Collaboration. Effects of lowering homocysteine levels with B vitamins on cardiovascular disease, cancer, and cause-specific mortality: Meta-analysis of 8 randomized trials involving 37 485 individuals. Arch Intern Med. 2010 Oct 11;170(18):1622-31. doi: 10.1001/archinternmed.2010.348.

  PMID: 20937919 BACKGROUND

• Devalia V, Hamilton MS, Molloy AM; British Committee for Standards in Haematology. Guidelines for the diagnosis and treatment of cobalamin and folate disorders. Br J Haematol. 2014 Aug;166(4):496-513. doi: 10.1111/bjh.12959. Epub 2014 Jun 18.

  PMID: 24942828 BACKGROUND

• Dong H, Pi F, Ding Z, Chen W, Pang S, Dong W, Zhang Q. Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials. PLoS One. 2015 Sep 10;10(9):e0137533. doi: 10.1371/journal.pone.0137533. eCollection 2015.

  PMID: 26355679 BACKGROUND

• Dudi, Parmila, Anita Rani, Bela Goyal, Geeta Kampani, Kamlesh Rabari, Ashish Kothari, and Sarama Saha. "Association of Vitamin B12 Transporter Protein (Transcobalamin II) Genetic Polymorphisms with Risk of Stroke: An Observational Pilot Study in North Indian Population." Meta Gene 25 (September 2020): 100747. https://doi.org/10.1016/j.mgene.2020.100747.

  BACKGROUND

• Duschek N, Basic J, Falkensammer J, Taher F, Assadian A. B-Vitamin Serum Concentrations Predicting Long-Term Overall and Stroke-Free Survival after Carotid Endarterectomy. J Stroke Cerebrovasc Dis. 2016 May;25(5):1235-1243. doi: 10.1016/j.jstrokecerebrovasdis.2016.01.044. Epub 2016 Feb 28.

  PMID: 26935113 BACKGROUND

• George PM, Steinberg GK. Novel Stroke Therapeutics: Unraveling Stroke Pathophysiology and Its Impact on Clinical Treatments. Neuron. 2015 Jul 15;87(2):297-309. doi: 10.1016/j.neuron.2015.05.041.

  PMID: 26182415 BACKGROUND

• Graham IM, Daly LE, Refsum HM, Robinson K, Brattstrom LE, Ueland PM, Palma-Reis RJ, Boers GH, Sheahan RG, Israelsson B, Uiterwaal CS, Meleady R, McMaster D, Verhoef P, Witteman J, Rubba P, Bellet H, Wautrecht JC, de Valk HW, Sales Luis AC, Parrot-Rouland FM, Tan KS, Higgins I, Garcon D, Andria G, et al. Plasma homocysteine as a risk factor for vascular disease. The European Concerted Action Project. JAMA. 1997 Jun 11;277(22):1775-81. doi: 10.1001/jama.1997.03540460039030.

  PMID: 9178790 BACKGROUND

• Green R, Allen LH, Bjorke-Monsen AL, Brito A, Gueant JL, Miller JW, Molloy AM, Nexo E, Stabler S, Toh BH, Ueland PM, Yajnik C. Vitamin B12 deficiency. Nat Rev Dis Primers. 2017 Jun 29;3:17040. doi: 10.1038/nrdp.2017.40.

  PMID: 28660890 BACKGROUND

• Hand PJ, Kwan J, Lindley RI, Dennis MS, Wardlaw JM. Distinguishing between stroke and mimic at the bedside: the brain attack study. Stroke. 2006 Mar;37(3):769-75. doi: 10.1161/01.STR.0000204041.13466.4c. Epub 2006 Feb 16.

  PMID: 16484610 BACKGROUND

• Huang X, Li Y, Li P, Li J, Bao H, Zhang Y, Wang B, Sun N, Wang J, He M, Yin D, Tang G, Chen Y, Cui Y, Huang Y, Hou FF, Qin X, Huo Y, Cheng X. Association between percent decline in serum total homocysteine and risk of first stroke. Neurology. 2017 Nov 14;89(20):2101-2107. doi: 10.1212/WNL.0000000000004648. Epub 2017 Oct 13.

  PMID: 29030456 BACKGROUND

Related Links

• Vitamin B 12 deficiency and hyperhomocysteinaemia in outpatients with stroke or transient ischaemic attack: a cohort study at an academic medical centre
• Missed Ischemic Stroke Diagnosis in the Emergency Department by Emergency Medicine and Neurology Services
• Ischaemic stroke
• Stroke
• Homocysteine metabolism, hyperhomocysteinaemia and vascular disease: an overview
• Biomarkers of cobalamin (vitamin B12) deficiency and its application
• Guidelines for the diagnosis and treatment of cobalamin and folate disorders
• Efficacy of Supplementation with B Vitamins for Stroke Prevention: A Network Meta-Analysis of Randomized Controlled Trials
• Novel Stroke Therapeutics: Unraveling Stroke Pathophysiology and Its Impact on Clinical Treatments
• Plasma homocysteine as a risk factor for vascular disease. The European Concerted Action Project
• Vitamin B12 deficiency
• Distinguishing between stroke and mimic at the bedside: the brain attack study
• Efficacy of folic acid therapy in primary prevention of stroke among adults with hypertension in China: the CSPPT randomized clinical trial

Biospecimen

Retention: SAMPLES WITH DNA

blood serum

MeSH Terms

Conditions

Hemorrhagic Stroke; Ischemic Stroke; Stroke; Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hiram Jaramillo, MD

CONTACT

6861358412; grupoinvestigacionmedica@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Serum Vitamin B12 levels in patients with hemorrhagic vs ischemic cerebrovascular event

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: November 13, 2023
• Primary Completion: July 1, 2024
• Study Completion: November 30, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)