EUCTR2022-002269-14-NL进行中（未招募）1 期
Dotatate to locate coronary plaques at high-risk of myocardial infarction
AMC, Cardiovascular Sciences0 个研究点目标入组 40 人开始时间: 2022年8月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Aged 50 years and older
- •- Underwent CCTA imaging within 78 weeks from the screening visit
- •- Either CAD-RADS 4 or higher or 0/1 on CCTA.
- •- Able to provide written informed consent
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI
- •value of < 45 ml/min/1,73m2.
- •- CVD events/revascularization in history
- •- Malignant diseases or any clinically significant medical condition that
- •could interfere with the conduct of the study in the opinion of the
- •investigator.
- •- Chronic or recent (< 1 month) infections and/or clinical signs of acute
- •- History of auto-immune diseases.
- •- Standard contra-indications to 68Ga-Dotatate PET, and CT based on
- •physicians experience and current practices.
- •- Inability or unwillingness to comply with the protocol requirements, or
- •deemed by investigator to be unfit for the study.
- •- Elevated liver enzymes (> 2 ULN of liver transaminases), acute liver
- •failure or known liver disease.
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