NCT05783804招募中不适用
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CAD Progression
研究概览
简要总结
This study evaluates whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, intensive lipid lowering therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with heterozygous familial hypercholesterolemia
- •Adult between 18 and 50 years old
- •LDL cholesterol levels above 100 mg/dl (>2.6 mmol/L) at inclusion
排除标准
- •Renal insufficiency, defined as eGFR < 30 ml/min
- •History of atherosclerotic cardiovascular events
- •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
CAD Progression
时间窗: 40 Weeks
Difference in total plaque volume between the initial and follow-up CCTA scan
次要结局
- Non-calcified plaque progression(40 Weeks)
- Calcified plaque progression(40 Weeks)
- Number of high-risk plaques(40 Weeks)
- Difference in Pericoronary Adipose Tissue Attenuation(40 Weeks)
研究者
E.S.stroes
Prof. dr. E.S.G. Stroes, MD, PhD.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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