ISRCTN15483452已完成未知
MINocyclinE to Reduce inflammation and blood brain barrier leakage in small Vessel diseAse (MINERVA) - A treatment trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36082255/ (added 29/11/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38629936/ (added 18/04/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Clinical evidence of cerebral small vessel disease as evidenced by one or more of;
- •1.1. A lacunar stroke syndrome (e.g., pure motor stroke, pure sensory stroke, sensorimotor stroke or ataxic hemiparesis, or clumsy hand dysarthria syndrome) with a corresponding acute lacunar infarct on diffusion weighted imaging (DWI) for cases imaged (clinically) within 3 weeks of stroke or an anatomically compatible lacunar infarct on FLAIR/T1 MRI for cases imaged later after stroke (<=1.5 cm diameter)
- •1.2. Symptoms of cognitive impairment
- •1.3. Gait apraxia
- •2. Confluent white matter hyper-intensities on T2 weighted MRI
- •3. If a past history of stroke at least 3 months after last stroke to exclude BBB changes secondary to acute infarction
排除标准
- •Current exclusion criteria as of 21/11/2019:
- •1. Unable/unwilling to consent
- •2. MMSE <21 (for consent issues)
- •3. Age <18 years
- •4. Lacunar infarcts >1.5 cm – as many of these are striatocapsular infarcts caused by embolism
- •5. Evidence of cortical stroke
- •6. Any stroke cause other than SVD including:
- •6.1. Cardioembolic source
- •6.2. Carotid or vertebral stenosis > 50% measured on NASCET criteria
- •7. Estimated glomerular filtration rate (eGFR) =<59 ml/min/1.73m2 within past 3 months. Estimated GFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation:
- •186 x (Creatinine / 88.4)1.154 x (Age) - 0.203 x (0.742 if female) x (1.210 if black)
- •8. Contraindications to taking part in MRI study, e.g., pacemaker
- •9. Inability to lie still in the PET/MR scanner for up to 75 minutes
- •10. Women who are of childbearing age, pregnant or breastfeeding
- •11. Meeting exclusions related to minocycline consumption, in particular:
- •11.1. Allergic to minocycline hydrochloride or other similar antibiotics
- •11.2. Have had complete kidney failure
- •11.3. Suffer from myasthenia gravis, have impaired liver or kidney function or have systemic lupus erythematosus (SLE)
- •11.4. Suffer from increased pressure in the skull
- •11.5. Are sensitive to sunlight or artificial light (e.g. sunbeds)
- •12. Taking medication contra-indicated to minocycline
- •Previous exclusion criteria:
- •1. Unable/unwilling to consent
- •2. MMSE <21 (for consent issues)
- •3. Age <18 years
- •4. Lacunar infarcts >1.5 cm – as many of these are striatocapsular infarcts caused by embolism
- •5. Evidence of cortical stroke
- •6. Any stroke cause other than SVD including:
- •6.1. Cardioembolic source
- •6.2. Carotid or vertebral stenosis >50% measured on NASCET criteria
- •7. Estimated glomerular filtration rate (eGFR) =<59 ml/min/1.73m2 within past 3 months. Estimated GFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation:
- •186 x (Creatinine / 88.4)1.154x (Age) - 0.203 x (0.742 if female) x (1.210 if black)
- •8. Contraindications to taking part in MRI study, e.g., pacemaker
- •9. Inability to lie still in the PET/MR scanner for up to 75 minutes
- •10. Women who are of childbearing age, pregnant or breastfeeding
- •11. Meeting exclusions related to minocycline consumption, in particular:
- •12. Allergic to minocycline hydrochloride, other similar antibiotics
- •13. Have had complete kidney failure
- •14. Suffer from myasthenia gravis, have impaired liver or kidney function, Have systemic lupus erythematosus (SLE)
- •15. Suffer from increased pressure in the skull
- •16. Are sensitive to sunlight or artificial light (e.g. sunbeds)
- •17. Taking medication contra-indicated to minocycline
研究者
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