Cerebrovascular EventViBEVCNCT06190314
SERUM VITAMIN B12 LEVELS IN PATIENTS WITH HEMORRHAGIC VS ISCHEMIC CEREBROVASCULAR EVENT.
An observational study of Cerebrovascular Event and Vitamin b12, run by Hospital General de Mexicali at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Event, Vitamin b12, Hemorrhagic Stroke
- What is being tested?
- Measure serum vitamin b12 levels
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 13 Nov 2023to 30 Nov 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Select all patients who arrive at the hospital who meet inclusion criteria and do not have any exclusion or elimination criteria.
Who may be able to join
- Age over 18 years
- Have a diagnosis of a cerebral vascular event
- Being a hospitalized patient at the General Hospital of Mexicali
Who cannot join
- Patients without lab tests during their hospitalization
- Patients without a cranial CT scan
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
General Hospital of Mexicali
Mexicali, Estado de Baja California, 21000
Hiram Jaramillo, MD, 6861358412, grupoinvestigacionmedica@gmail.com
About this study
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.
Read the 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.
- Being tested
- Measure serum vitamin b12 levels
- Keywords
- Stroke, Hemorrhagic, B12, Ischemic
- Medical subject headings
- Hemorrhagic Stroke, Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure serum vitamin b12 levelsDiagnostic test
Measure the vitamin b-12 levels in patients that are admitted for stroke of any kind
| Study group | Role | What they receive |
|---|---|---|
| patients with ischemic stroke | measure serum vitamin b12 levels Receives: Diagnostic Test: Measure serum vitamin b12 levels | |
| patients with hemorrhagic stroke | measure serum vitamin b12 levels Receives: Diagnostic Test: Measure serum vitamin b12 levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: November 2023 - November 2024
Secondary outcomes (4)
Vitamin B12 defficiency in patients with stroke
Vitamin B12 defficiency in patients with any kind of stroke
Measured: November 2023 - November 2024
Population characteristics
Determine if variables like sex, age, comorbilities and lab tests have a correlation between stroke and Vitamin B12 levels
Measured: November 2023 - November 2024
Mortality and vitamin B 12 deficiency in this specific population
Analize the levels of vitamin B12 and the in-hospital mortality in this population
Measured: November 2023 - November 2024
Levels of B12 vitamin and severity of stroke
Analize if there is a significant difference between the levels of B12 and the severity of stroke
Measured: November 2023 - November 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start13 Nov 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexicali
- Sponsor type
- University, hospital or other
- Collaborators
- Sandoval Briones Jocelin Lisset, Hirata Medina Nancy Midory, Felix Escobedo Marisol, Cervantes De Carlos Cereza Guadalpe, Aceves Lozano Natalia, Cota Andara Manuel Eduardo, Avila Pacheco Manlio Abraham, Rodriguez Gonzalez Alondra, Barruquin Sandoval Claudia Pamela, González Gómez René Ignacio, Jaramillo Ramirez Hiram Javier.
- Responsible party
- Principal investigator, Hiram Jaramillo Ramirez, Hospital General de Mexicali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190314
- Sponsor's protocol ID
- 02-01-HGMXL/CEI/2023-23
- Acronym
- ViBEVC
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30670531Arch 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.
PubMed 26846858Bick 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.
PubMed 8170260Bjorklund 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.
PubMed 33724098Campbell 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.
PubMed 31601801Campbell BCV, Khatri P. Stroke. Lancet. 2020 Jul 11;396(10244):129-142. doi: 10.1016/S0140-6736(20)31179-X.
PubMed 32653056Castro 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.
PubMed 16601863Chatthanawaree 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.
PubMed 21369672Clarke 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.
PubMed 20937919Devalia 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.
PubMed 24942828Dong 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.
PubMed 26355679Dudi, 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.
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.
PubMed 26935113George 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.
PubMed 26182415Graham 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.
PubMed 9178790
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERUM VITAMIN B12 LEVELS IN PATIENTS WITH HEMORRHAGIC VS ISCHEMIC CEREBROVASCULAR EVENT.
- ClinicalTrials.gov ID
- NCT06190314
- Acronym / sponsor ID
- ViBEVC / 02-01-HGMXL/CEI/2023-23
- Keywords
- Stroke, Hemorrhagic, B12, Ischemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General de MexicaliUniversity, hospital or other
- Collaborators
- Sandoval Briones Jocelin Lisset, Hirata Medina Nancy Midory, Felix Escobedo Marisol, Cervantes De Carlos Cereza Guadalpe, Aceves Lozano Natalia, Cota Andara Manuel Eduardo, Avila Pacheco Manlio Abraham, Rodriguez Gonzalez Alondra, Barruquin Sandoval Claudia Pamela, González Gómez René Ignacio, Jaramillo Ramirez Hiram Javier.
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with ischemic stroke | – | Diagnostic Test: Measure serum vitamin b12 levelsmeasure serum vitamin b12 levels |
| patients with hemorrhagic stroke | – | Diagnostic Test: Measure serum vitamin b12 levelsmeasure serum vitamin b12 levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Select all patients who arrive at the hospital who meet inclusion criteria and do not have any exclusion or elimination criteria.
Key inclusion criteria (3 listed)
- Age over 18 years
- Have a diagnosis of a cerebral vascular event
- Being a hospitalized patient at the General Hospital of Mexicali
Key exclusion criteria (2 listed)
- Patients without lab tests during their hospitalization
- Patients without a cranial CT scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure serum vitamin b12 levelsMeasure the vitamin b-12 levels in patients that are admitted for stroke of any kind | Diagnostic test | patients with hemorrhagic stroke, patients with ischemic stroke |
Primary outcome
Difference of vitamin B12 level between ischemic and hemorrhagic stroke
Time frame: 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.
4 secondary outcomes
Vitamin B12 defficiency in patients with stroke
Time frame: November 2023 - November 2024
Population characteristics
Time frame: November 2023 - November 2024
Mortality and vitamin B 12 deficiency in this specific population
Time frame: November 2023 - November 2024
Levels of B12 vitamin and severity of stroke
Time frame: November 2023 - November 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 30670531Ahmed 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.
- Background: PubMed 26846858Arch 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.
- Background: PubMed 8170260Bick 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.
- Background: PubMed 33724098Bjorklund 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.
- Background: PubMed 31601801Campbell 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.
- Background: PubMed 32653056Campbell BCV, Khatri P. Stroke. Lancet. 2020 Jul 11;396(10244):129-142. doi: 10.1016/S0140-6736(20)31179-X.
- Background: PubMed 16601863Castro 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.
- Background: PubMed 21369672Chatthanawaree 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.
- Background: PubMed 20937919Clarke 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.
- Background: PubMed 24942828Devalia 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.
- Background: PubMed 26355679Dong 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.
- BackgroundDudi, 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.
- Vitamin B 12 deficiency and hyperhomocysteinaemia in outpatients with stroke or transient ischaemic attack: a cohort study at an academic medical centreLink provided by the sponsor.
- Missed Ischemic Stroke Diagnosis in the Emergency Department by Emergency Medicine and Neurology ServicesLink provided by the sponsor.
- Ischaemic strokeLink provided by the sponsor.
- StrokeLink provided by the sponsor.
- Homocysteine metabolism, hyperhomocysteinaemia and vascular disease: an overviewLink provided by the sponsor.
- Biomarkers of cobalamin (vitamin B12) deficiency and its applicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cerebrovascular Event
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Event and Vitamin b12, run by Hospital General de Mexicali at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiram Jaramillo, MD (6861358412, grupoinvestigacionmedica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of vitamin B12 level between ischemic and hemorrhagic stroke (time frame: November 2023 - November 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06190314, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.