NCT05536960已完成不适用
Dotatate to Locate Coronary Plaques at High-risk of Myocardial Infarction
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年9月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Difference in TBRmax
研究概览
简要总结
To assess whether vulnerable coronary plaques have more uptake of 68Ga-Dotatate than non-vulnerable plaques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
排除标准
- •History of chronic kidney disease stage 3b - 5, defined as a CKD-EPI value of < 45 ml/min/1,73m
- •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 infection.
- •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.
结局指标
主要结局
Difference in TBRmax
时间窗: 1 day
Difference of target to background ratio (TBR)max in the coronary arteries between groups.
次要结局
- Correlation between TBRmax and FAI.(1 day)
研究者
E.S.stroes
Prof. Dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (2)
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