Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Coronary Artery Contrast-enhanced Magnetic Resonance Contrast-enhanced Angiography
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Retinol binding protein
研究概览
简要总结
This is a single-center, prospective, controlled and diagnostic clinical trial which will enroll 30 patients scheduled for coronary angiography in China.Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.In order to evaluate the safety of polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in peripheral and tissue before and after the examination.The main indicators of the study are the degree of coronary artery stenosis and the stability of coronary atherosclerotic plaque assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≧ 18 years, < 75 years;
- •Patients who planned coronary angiography ;
- •Patients with normal renal function or CKD stage 1-3;
- •Patients themselves or authorized families to sign informed consent voluntarily.
排除标准
- •Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
- •Patients who can ' t accept magnetic resonance examination because of psychological ( such as autism syndrome ) or physical reasons ( such as metal retention in the body );
- •Malignancies or other comorbid conditions with life expectancy less than 1 year;
- •Pregnant or lactating woman;
- •Hearing impaired persons;
- •Cardiac function grade III-IV;
- •History of coronary stenting or coronary artery bypass grafting;
- •Patients who were taking other iron agents orally or intravenously;
- •Patients with hemosiderin deposition or hemochromatosis;
- •Patients with acute coronary syndromes;
- •Any other patients that researcher deems it's unsuitable to be admitted.
研究组 & 干预措施
ECMR
Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.
干预措施: domestic polysaccharide superparamagnetic iron oxide nanoparticle (Drug)
结局指标
主要结局
Retinol binding protein
时间窗: baseline,72 hours,30 Days,3 months
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Blood routine
时间窗: baseline,72 hours,30 Days,3 months
Blood routine examination of patients before and after examination to evaluate general condition of patients.
The degree of coronary artery stenosis
时间窗: 72 hours
Degree of coronary artery stenosis assessed by quantitative coronary angiography.
Plaque stability of coronary atherosclerotic plaques
时间窗: 72 hours
Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.
Blood biochemistry
时间窗: baseline,72 hours,30 Days,3 months
Blood biochemistry examination of patients before and after examination to evaluate liver function.
Urine routine
时间窗: baseline,72 hours,30 Days,3 months
Urine routine examination of patients before and after examination to evaluate kidney function.
24-hour urine biochemistry
时间窗: baseline,72 hours,30 Days,3 months
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Neutrophil gelatinase-associated lipocalin
时间窗: baseline,72 hours,30 Days,3 months
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Serum iron
时间窗: baseline,72 hours,30 Days,3 months
Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.
Ferritin
时间窗: baseline,72 hours,30 Days,3 months
Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Transferrin
时间窗: baseline,72 hours,30 Days,3 months
Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Change of iron content in tissues between different time points
时间窗: baseline,6 months
Evaluation of tissue iron content by T1W MRI before and after ECMR.
次要结局
未报告次要终点
研究者
Chunjian Li
Dr., MD, Ph.D, Director of CCU Ward
The First Affiliated Hospital with Nanjing Medical University