Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Degree of vascular stenosis at the site of coronary calcification.
研究概览
简要总结
This study is a single-center, prospective, controlled, diagnostic study. The study will be consecutive and is expected to enroll 100 patients with CCTA confirmed coronary calcified lesions. The purpose of this study was to compare the accuracy of novel Ferumoxytol-enhanced Cardiac Magnetic Resonance (Fe-CMR) and coronary CT angiography (CCTA) in detecting calcified coronary arteries, using coronary angiography (CAG) and optical coherence imaging (OCT) as gold standards.
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 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;
- •Imaging specialists evaluate CCTA images taken within 30 days and report that calcification occupied one or more of the patient's vascular lumen at an angle of >50% (using the coronary artery segmentation method recommended by the American Heart Association, including nine segments of the major branches of the coronary artery);
- •Patient who will undergo coronary angiography;
- •Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3;
- •Patient who signs the informed consent.
排除标准
- •People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves;
- •Because of psychological (such as suffering from claustrophobic syndrome) or physical reasons (such as the presence of metal objects in the body) can not receive MRI examination;
- •suffering from terminal diseases (such as malignant tumors) or life expectancy < 1 year;
- •Pregnant or lactating women;
- •People with limited hearing;
- •Patients with grade III-IV heart function;
- •Patients with a history of coronary artery stent implantation or coronary artery bypass;
- •Other iron agents are being used orally or intravenously;
- •Patients with hemosiderosis or hemochromatosis;
- •Patients with acute coronary syndrome;
- •Patients with hyperthyroidism;
- •Any other candidates deemed unsuitable by the researchers.
研究组 & 干预措施
patients with calcified lesions
A novel ferumoxytol-enhanced cardiac magnetic resonance imaging and coronary angiography are performed in patients with CCTA proven calcified lesions occupying greater than 50% of the angle of the vascular lumen.
干预措施: Superparamagnetic Iron Oxide Nanoparticles (Drug)
结局指标
主要结局
Degree of vascular stenosis at the site of coronary calcification.
时间窗: baseline
Degree of vascular stenosis at the site of coronary calcification(measured by CAG, CCTA, Fe-CMRA): 0-100%.
次要结局
- CT-FFR, Agatston score, and the angle of calcification lesions occupying vascular lumen(baseline)
- calcium score of the plaque measured by OCT(baseline)
- Fe-CMRA image quality score(baseline)
研究者
Chunjian Li
Director of Cardiology
The First Affiliated Hospital with Nanjing Medical University