Division of Cardiology, Robert-Bosch-Krankenhaus, Stuttgart, Germany.
Int J Cardiol. 2013 Feb 20;163(2):175-82. doi: 10.1016/j.ijcard.2011.06.004.
Superparamagnetic iron oxide nanoparticle (SPIO)-based molecular imaging agents targeting macrophages have been developed and successfully applied in animal models of myocardial infarction. The purpose of this clinical trial was to investigate whether magnetic resonance imaging (MRI) of macrophages using ferucarbotran (Resovist®) allows improved visualisation of the myocardial (peri-)infarct zone compared to conventional gadolinium-based necrosis/fibrosis imaging in patients with acute myocardial infarction.
The clinical study NIMINI-1 was performed as a prospective, non-randomised, non-blinded, single agent phase III clinical trial (NCT0088644). Twenty patients who had experienced either an acute ST-elevation or non-ST-elevation myocardial infarction (STEMI/NSTEMI) were included to this study. Following coronary angiography, a first baseline cardiovascular magnetic resonance (CMR) study (pre-SPIO) was performed within seven days after onset of cardiac symptoms. A second CMR study (post-SPIO) was performed either 10 min, 4h, 24h or 48h after ferucarbotran administration. The CMR studies comprised cine-CMR, T2-weighted "edema" imaging, T2-weighted cardiac imaging and T1-weighted late-gadolinium-enhancement (LGE) imaging.
The median extent of short-axis in-plane LGE was 28% (IQR 19-31%). Following Resovist® administration the median extent of short-axis in-plane T2-weighted hypoenhancement (suggestive of intramyocardial haemorrhage and/or SPIO accumulation) was 0% (IQR 0-9%; p=0.68 compared to pre-SPIO). A significant in-slice increase (>3%) in the extent of T2-weighted "hypoenhancement" (post-SPIO compared to pre-SPIO) was seen in 6/16 patients (38%). However, no patient demonstrated "hypoenhancement" in T2-weighted images following Resovist® administration that exceeded the area of LGE.
T2/T2-weighted MRI aiming at non-invasive myocardial macrophage imaging using the approved dose of ferucarbotran does not allow improved visualisation of the myocardial (peri-) infarct zone compared to conventional gadolinium-based necrosis/fibrosis imaging.
针对巨噬细胞的超顺磁性氧化铁纳米颗粒（SPIO）为基础的分子成像剂已被开发并成功应用于心肌梗死动物模型。本临床试验的目的是研究在急性心肌梗死患者中，使用钆塞酸二钠（Resovist®）进行磁共振成像（MRI）是否能比传统的基于钆的坏死/纤维化成像更好地显示心肌（周边）梗死区。
临床研究 NIMINI-1 是一项前瞻性、非随机、非盲、单药 III 期临床试验（NCT0088644）。纳入了 20 名经历过急性 ST 段抬高或非 ST 段抬高心肌梗死（STEMI/NSTEMI）的患者。在冠状动脉造影后，在心脏症状发作后 7 天内进行首次基线心血管磁共振（CMR）研究（预 SPIO）。在钆塞酸二钠给药后 10 分钟、4 小时、24 小时或 48 小时进行第二次 CMR 研究（post-SPIO）。CMR 研究包括电影 CMR、T2 加权“水肿”成像、T2 加权心脏成像和 T1 加权晚期钆增强（LGE）成像。
短轴平面内 LGE 的中位数范围为 28%（IQR 19-31%）。钆塞酸二钠给药后，短轴平面内 T2 加权低信号区的中位数范围为 0%（IQR 0-9%；与预 SPIO 相比，p=0.68）。在 16 名患者中有 6 名（38%）的 T2 加权“低信号区”（post-SPIO 与 pre-SPIO 相比）的信号强度有显著的切片内增加（>3%）。然而，没有患者在钆塞酸二钠给药后显示 T2 加权图像中的“低信号区”超过 LGE 面积。
使用批准剂量的钆塞酸二钠进行 T2/T2 加权 MRI 靶向非侵入性心肌巨噬细胞成像，与传统的基于钆的坏死/纤维化成像相比，不能改善心肌（周边）梗死区的可视化。
