NCT05352386已完成不适用
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2022年3月7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
- 135
- 试验地点
- 1
- 主要终点
- Total coronary plaque burden (%)
研究概览
简要总结
This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with heterozygous familial hypercholesterolemia or non FH-control
- •Adult patients between 25 and 55 years old.
排除标准
- •Renal insufficiency, defined as eGFR < 30 ml/min
- •Atrial fibrillation
- •Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
- •Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
结局指标
主要结局
Total coronary plaque burden (%)
时间窗: Day 0
Total coronary plaque volume (mm3)
时间窗: Day 0
次要结局
- Plasma apolipoprotein B (g/l)(Day 0)
- Presence of >50% obstructive stenosis per vessel(Day 0)
- Calcified coronary plaque burden (%)(Day 0)
- Non-calcified plaque burden (%)(Day 0)
- Low attenuation plaque burden (%)(Day 0)
- Presence of <50% nonobstructive stenosis per vessel(Day 0)
- Calcified coronary plaque volume (mm^3)(Day 0)
- Non-calcified plaque volume (mm^3)(Day 0)
- Pericoronary adipose tissue attenuation (Hounsfield units)(Day 0)
- Plasma LDL cholesterol (mmol/l)(Day 0)
- Low attenuation plaque volume (mm^3)(Day 0)
- Number of high risk plaque features (positive remodeling, low attenuation plaque, spotty calcification and napkin ring sign)(Day 0)
研究者
E.S.stroes
Prof. dr. E.S.G.Stroes
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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