EUCTR2015-005752-10-GB进行中（未招募）1 期
The relationship between computerised tomographic coronary angiography (CTCA) calcium scoring and endothelial progenitor cell (EPC) count. Study A and B. - The relationship between CTCA and EPC count.
niversity Hospitals of North Midlands NHS Trust0 个研究点目标入组 70 人开始时间: 2016年12月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
入选标准
- •Patient-participants will be eligible for the study if they are;
- •> 18 years of age
- •Patient-participant that have undergone a coronary artery CTCA calcium score as part of clinical care
- •Patient-participants will be eligible for the study if they are;
- •> 18 years of age
- •CTCA score of >101
- •Statin niave or receiving a statin other than atorvastatin, or atorvastatin <80mg/day
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Part A and B:
- •Patient-participants will be excluded if they are unable to;
- •1.Give informed consent
- •2.Attend follow up clinic
- •Excluded if they have a prior history of:
- •Chronic renal failure (eGFR <30).
- •Significant hepatic disease(3x upper limit of normal liver profile).
- •Prior coronary artery bypass graft surgery, as these patients will have a high calcium score in native coronary arteries
- •Unable to give informed consent
- •Unable to attend follow up clinic
- •Contraindications to statin therapy as per clinical judgement
- •Excluded if they have a prior history of:
- •Adverse reaction to statin therapy
- •Chronic renal failure (eGFR <30 (based on recent clinical care sample within 2 months prior)).
- •Significant hepatic disease (3x upper limit of normal liver profile(based on recent clinical care sample within 2 months prior)).•
- •Prior coronary artery bypass graft surgery, as these patients will have a high calcium score in native coronary arteries
- •Women of child bearing potential unless they are using a recognised effective form of contraception or are not sexually active, and have no intention of becoming sexually active during the course of the trial
- •Women who are breast feeding
研究者
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