NL-OMON48763招募中2 期
Cerebrovascular reserve and white matter disease in patients with chronic anemia. (IMPROvE) - IMPROvE
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria (patient groups)
- •Sickle cell disease
- •Thalassemia major, thalassemia intermedia, and HbH disease
- •18 Years of age or older
- •Informed consent;Inclusion criteria control group
- •Either AS or AA haemoglobin,
- •18 Years of age or older
- •Informed consent
排除标准
- •Exclusion criteria (patient groups)
- •Hospitalization in the past month for any reason
- •Inability of the patient to provide informed consent
- •Contraindications for MRI, such as claustrophobia or the presence of metal in the body
- •Sickle cell crisis at the moment of participation up to one month prior to participation
- •History of cerebral pathology that compromises measurements, such as cerebral palsy, brain tumour, meningitis, overt infarct
- •Brain surgery performed in the last 3 months ;ACZ contraindications
- •Severe liver, heart or renal dysfunction (clearance < 10 mL/min)
- •Allergy to sulphonamide
- •Pregnant or breastfeeding
- •Use of phenytoin, procaine or acetylsacylic acid (*Ascal/aspirin*)
- •Risk of hypokalaemia (use of diuretics, primary hyperaldosteronism)
- •Addison*s Disease
- •Severe asthma or emphysema ;Exclusion criteria (controls)
- •Any known chronic illness that may compromise subject safety or data integrity. These include but are not limited to rheumatologic disorders, malignancy, severe asthma, chronic hepatic or renal insufficiency, and haemoglobinopathy or other chronic anaemia
- •Vascular risk factors
- •Hypercholesterolemia
- •Contraindications for MRI, such as claustrophobia or the presence of metal in the body
- •Contraindications for ACZ (listed in the exclusion criteria of patients)
- •Developmental delay, stroke, seizure disorder, or neurological conditions other than simple migraine
- •Inability to cooperate with MRI examinations
- •Uncontrolled hypertension or history of hypertension
研究者
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