EUCTR2021-005501-27-DK进行中（未招募）1 期
64Cu-DOTATATE PET/CT-skanning to diagnose macrophage infiltation in the heart valves of patients with infectiv endocarditis.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years old
- •Be able to understand given information and sign informered consent
- •Group A: native heart valves without clinical or paraclinical sign of infection
- •Group B: native heart valves with verified endocarditis (according to modified Duke-criteria)
- •Group C: prothethic heart valves(mechanical or biological) without clinical or paraclinical sign of infection and more >1 year sind the heart
- •Group D: infected prothethic heart valves, in addition clinical and paraclinical signs of infection (blood cultures and samples) and echocardiography
- •Group E: newly operated in the heart valves without infection (6 months since operation)
- •Group F: newly heart valve operation due to endocarditis (6 monts since operation)
- •Group G: chronical infection in the aortic valce - lifelong antibiotics.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-allergi for 64Cu-DOTATATE or 18-FDG
- •-obesity(weight over 140 kg)
- •-critically ill, and PET scan not possible
- •-Pregnancy or suspected pregnancy - negativ hCG will be required for fertile women
- •-severe claustrophobia
- •-diabetes - defined by farmacological treatment
- •-recent heart operation(<4 weeks)
研究者
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