新型铁氧体增强冠状动脉磁共振血管造影的诊断性能和安全性。
Diagnostic Performance and Safety of a Novel Ferumoxytol-Enhanced Coronary Magnetic Resonance Angiography.
机构信息
Department of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (Z.D., C.L., R.H., J.T., W.Z., T.W., X.G., Z.T., Z.X., Y.L., B.C., X.K., C.L.).
State Key Laboratory of Bioelectronics, Jiangsu Key Laboratory for Biomaterials and Devices, Southeast University, Nanjing, China (G.S., N.G.).
出版信息
Circ Cardiovasc Imaging. 2023 Jul;16(7):580-590. doi: 10.1161/CIRCIMAGING.123.015404. Epub 2023 Jul 18.
BACKGROUND
Currently, noninvasive arteriography for the diagnosis of coronary artery disease is clinically limited to the computed tomography scanning, where patients have to be exposed to the radiation and risks associated with iodinated contrast. We aimed to investigate the diagnostic performance and safety of a novel ferumoxytol-enhanced coronary magnetic resonance angiography (CMRA) in patients with suspected coronary artery disease.
METHODS
Thirty patients, 19 males, with a median age of 63 years old, and 17 with renal insufficiency, who were scheduled for invasive coronary angiography, were enrolled. Ferumoxytol was administered intravenously with a dose of 3 mg/kg during CMRA. Images were acquired with an ECG-triggered, navigator-gated, inversion recovery-prepared 3D fast low-angle shot sequence, and the image quality was assessed by a 4-point scale. Eighteen-segment coronary artery model was adopted to evaluate the visibility of the coronary arteries, and the image quality and stenosis were evaluated in nine segments. The diagnostic performance of CMRA is described as sensitivity, specificity, positive and negative predictive values, and accuracy with the invasive coronary angiography results as reference. The patients' vital signs were monitored during CMRA, and their hepatic and renal functions were followed up for 3 months to evaluate the safety of ferumoxytol.
RESULTS
Two hundred fifty-two of the 270 study segments were identified by CMRA, and their quality score reached 3.6±0.7. Referring to the invasive coronary angiography results, the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ferumoxytol-enhanced CMRA reached 100.0%, 66.7%, 92.3%, 100.0%, and 93.3% respectively in patient-based analysis; 91.4%, 90.9%, 86.5%, 94.3%, and 91.1%, respectively in vessel-based analysis; and 92.3%, 96.7%, 83.7%, 98.6%, and 96.0%, respectively in segment-based analysis. No ferumoxytol-related adverse event was observed during the 3-month follow-up.
CONCLUSIONS
Ferumoxytol-enhanced CMRA demonstrated good diagnostic performance and excellent safety in the diagnosis of significant coronary stenosis, providing an alternative to coronary computed tomography angiography for the diagnosis of coronary artery disease.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT05032937.
背景
目前，用于诊断冠状动脉疾病的非侵入性动脉造影术在临床上仅限于计算机断层扫描，患者必须接受辐射和碘对比剂相关的风险。我们旨在研究新型铁氧体增强冠状动脉磁共振血管造影（CMRA）在疑似冠状动脉疾病患者中的诊断性能和安全性。
方法
共纳入 30 名患者，19 名男性，中位年龄 63 岁，17 名肾功能不全，计划行冠状动脉造影术。CMRA 时静脉给予铁氧体 3mg/kg。使用 ECG 触发、导航门控、反转恢复准备 3D 快速低角度拍摄序列采集图像，图像质量采用 4 分制进行评估。采用 18 节段冠状动脉模型评估冠状动脉的可视性，并在 9 个节段评估图像质量和狭窄程度。CMRA 的诊断性能描述为以有创冠状动脉造影结果为参考的敏感性、特异性、阳性预测值、阴性预测值和准确性。在 CMRA 期间监测患者生命体征，并随访 3 个月以评估铁氧体的安全性。
结果
CMRA 识别了 270 个研究段中的 252 个，其质量评分达到 3.6±0.7。以有创冠状动脉造影结果为参考，患者水平分析中铁氧体增强 CMRA 的敏感性、特异性、阳性预测值、阴性预测值和准确性分别为 100.0%、66.7%、92.3%、100.0%和 93.3%；血管水平分析中分别为 91.4%、90.9%、86.5%、94.3%和 91.1%；节段水平分析中分别为 92.3%、96.7%、83.7%、98.6%和 96.0%。在 3 个月的随访中未观察到与铁氧体相关的不良事件。
结论
铁氧体增强 CMRA 在诊断显著冠状动脉狭窄方面具有良好的诊断性能和优异的安全性，为冠状动脉疾病的诊断提供了一种替代冠状动脉计算机断层扫描的方法。
登记
网址：https://www.clinicaltrials.gov；独特标识符：NCT05032937。
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