Bulluck Heerajnarain, Hammond-Haley Matthew, Weinmann Shane, Martinez-Macias Roberto, Hausenloy Derek J
The Hatter Cardiovascular Institute, Institute of Cardiovascular Science, University College London, United Kingdom; The National Institute of Health Research University College London Hospitals Biomedical Research Center, London, United Kingdom; National Heart Research Institute Singapore, National Heart Center Singapore, Singapore, Singapore.
The Hatter Cardiovascular Institute, Institute of Cardiovascular Science, University College London, United Kingdom.
JACC Cardiovasc Imaging. 2017 Mar;10(3):230-240. doi: 10.1016/j.jcmg.2017.01.008.
The aim of this study was to review randomized controlled trials (RCTs) using cardiac magnetic resonance (CMR) to assess myocardial infarct (MI) size in reperfused patients with ST-segment elevation myocardial infarction (STEMI).
There is limited guidance on the use of CMR in clinical cardioprotection RCTs in patients with STEMI treated by primary percutaneous coronary intervention.
All RCTs in which CMR was used to quantify MI size in patients with STEMI treated with primary percutaneous coronary intervention were identified and reviewed.
Sixty-two RCTs (10,570 patients, January 2006 to November 2016) were included. One-third did not report CMR vendor or scanner strength, the contrast agent and dose used, and the MI size quantification technique. Gadopentetate dimeglumine was most commonly used, followed by gadoterate meglumine and gadobutrol at 0.20 mmol/kg each, with late gadolinium enhancement acquired at 10 min; in most RCTs, MI size was quantified manually, followed by the 5 standard deviation threshold; dropout rates were 9% for acute CMR only and 16% for paired acute and follow-up scans. Weighted mean acute and chronic MI sizes (≤12 h, initial TIMI [Thrombolysis in Myocardial Infarction] flow grade 0 to 3) from the control arms were 21 ± 14% and 15 ± 11% of the left ventricle, respectively, and could be used for future sample-size calculations. Pre-selecting patients most likely to benefit from the cardioprotective therapy (≤6 h, initial TIMI flow grade 0 or 1) reduced sample size by one-third. Other suggested recommendations for standardizing CMR in future RCTs included gadobutrol at 0.15 mmol/kg with late gadolinium enhancement at 15 min, manual or 6-SD threshold for MI quantification, performing acute CMR at 3 to 5 days and follow-up CMR at 6 months, and adequate reporting of the acquisition and analysis of CMR.
There is significant heterogeneity in RCT design using CMR in patients with STEMI. The authors provide recommendations for standardizing the assessment of MI size using CMR in future clinical cardioprotection RCTs.
本研究旨在回顾利用心脏磁共振成像（CMR）评估接受再灌注治疗的ST段抬高型心肌梗死（STEMI）患者心肌梗死（MI）面积的随机对照试验（RCT）。
在接受直接经皮冠状动脉介入治疗的STEMI患者的临床心脏保护RCT中，关于CMR使用的指导有限。
识别并回顾了所有使用CMR对接受直接经皮冠状动脉介入治疗的STEMI患者的MI面积进行量化的RCT。
纳入了62项RCT（10570例患者，2006年1月至2016年11月）。三分之一的研究未报告CMR设备供应商或扫描仪强度、所用造影剂及剂量，以及MI面积量化技术。钆喷酸葡胺最常使用，其次是钆特酸和钆布醇，各为0.20 mmol/kg，延迟钆增强在10分钟时采集；在大多数RCT中，MI面积通过手动量化，其次是5标准差阈值；仅急性CMR的失访率为9%，急性和随访扫描配对的失访率为16%。对照组加权平均急性和慢性MI面积（≤12小时，初始心肌梗死溶栓治疗（TIMI）血流分级0至3）分别为左心室的21±14%和15±11%，可用于未来样本量计算。预先选择最可能从心脏保护治疗中获益的患者（≤6小时，初始TIMI血流分级0或1）可使样本量减少三分之一。未来RCT中CMR标准化的其他建议包括：钆布醇0.15 mmol/kg，延迟钆增强在15分钟时采集，MI量化采用手动或6标准差阈值，在3至5天进行急性CMR，在6个月进行随访CMR，以及充分报告CMR的采集和分析情况。
在STEMI患者中使用CMR的RCT设计存在显著异质性。作者为未来临床心脏保护RCT中使用CMR标准化评估MI面积提供了建议。
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