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A real-world patient registry study on the efficacy of B-vitamin therapy for acute ischemic stroke based on cerebral small vessel disease

A real-world patient registry study on the efficacy of B-vitamin therapy for acute ischemic stroke based on cerebral small vessel disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500115080
Enrollment
Unknown
Registered
2025-12-22
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

ischemic stroke

Interventions

Homocysteine-lowering treatment group:None

Sponsors

Shanxi Bethune Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent form; 2. Patients with ischemic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 72 hours of onset; 3. Aged 18-80 years; 4. Fasting blood homocysteine (Hcy) >= 10 µmol/L.

Exclusion criteria

Exclusion criteria: 1. Long-term use of folic acid/B vitamins or homocysteine (Hcy)-lowering drugs (> 1 month); 2. Stroke with other clear etiologies (e.g., cardiogenic embolism, arterial dissection, vasculitis); 3. Patients who received emergency intravenous thrombolytic therapy; 4. Severe hepatic and renal insufficiency (eGFR 3 times the upper limit of normal); 5. Severe chronic cardiopulmonary diseases, which the investigator deems unfit for participation in the project; 6. Patients with an expected life span of less than 1 year or those unable to complete the study for other reasons; 7. Lactating women, individuals with fertility plans, and patients taking methotrexate for any reason; 8. Participants in other clinical trials; 9. Presence of violent tendencies and inability to cooperate; 10. Residents not living in the area long-term and unable to cooperate with follow-up.

Design outcomes

Primary

MeasureTime frame
Composite events of stroke recurrence, myocardial infarction, and vascular death;

Secondary

MeasureTime frame
Ischemic stroke;Hemorrhage stroke;Myocardial infarction;vascular death and all cause death;Transient Ischemic Attack;Disability;Post-stroke depression;The change ranges of serum folic acid, vitamin B12, and serum homocysteine;

Countries

China

Contacts

Public ContactKaili Zhang

Shanxi Bethune Hospital

zhangkaili-2009@163.com+86 351 217 0934

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026