Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, 6-1 Kishibe-shimmachi, Suita, 564-8565, Japan.
Department of Diagnostic Radiology, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.
Trials. 2022 Oct 24;23(1):904. doi: 10.1186/s13063-022-06820-w.
Although screening for coronary artery disease (CAD) using computed tomography coronary angiography in patients with stable chest pain has been reported to be beneficial, patients with chronic kidney disease (CKD) might have limited benefit due to complications of contrast agent nephropathy and decreased diagnostic accuracy as a result of coronary artery calcifications. Cardiac magnetic resonance (CMR) has emerged as a novel imaging modality for detecting coronary stenosis and high-risk coronary plaques without contrast media that is not affected by coronary artery calcification. However, the clinical use of this technology has not been robustly evaluated.
AQUAMARINE-CKD is an open parallel-group prospective multicenter randomized controlled trial of 524 patients with CKD at high risk for CAD estimated based on risk factor categories for a Japanese urban population (Suita score) recruited from 6 institutions. Participants will be randomized 1:1 to receive a CMR examination that includes non-contrast T1-weighted imaging and coronary magnetic angiography (CMR group) or standard examinations that include stress myocardial scintigraphy (control group). Randomization will be conducted using a web-based system. The primary outcome is a composite of cardiovascular events at 1 year after study examinations: all-cause death, death from CAD, nonfatal myocardial infarction, nonfatal ischemic stroke, and ischemia-driven unplanned coronary intervention (percutaneous coronary intervention or coronary bypass surgery).
If the combination of T1-weighted imaging and coronary magnetic angiography contributes to the risk assessment of CAD in patients with CKD, this study will have major clinical implications for the management of patients with CKD at high risk for CAD.
Japan Registry of Clinical Trials (jRCT) 1,052,210,075. Registered on September 10, 2021.
虽然在稳定型胸痛患者中使用计算机断层扫描冠状动脉造影进行冠状动脉疾病（CAD）筛查已被证明有益，但由于对比剂肾病的并发症以及由于冠状动脉钙化导致诊断准确性降低，慢性肾脏病（CKD）患者可能获益有限。心脏磁共振（CMR）已成为一种新型的成像方式，可在不使用造影剂的情况下检测冠状动脉狭窄和高危冠状动脉斑块，且不受冠状动脉钙化的影响。然而，该技术的临床应用尚未得到充分评估。
AQUAMARINE-CKD 是一项在日本城市人群（Suita 评分）风险因素类别基础上，估计患有 CAD 高风险的 524 例 CKD 患者的开放、平行组、前瞻性、多中心随机对照试验。该试验共招募了来自 6 家机构的患者。参与者将被随机分为 1:1 接受 CMR 检查（包括非对比 T1 加权成像和冠状动脉磁共振血管造影术，CMR 组）或标准检查（包括应激心肌闪烁显像，对照组）。随机化将通过基于网络的系统进行。主要终点是研究检查后 1 年的心血管事件综合结果：全因死亡、CAD 死亡、非致死性心肌梗死、非致死性缺血性卒中和缺血驱动的计划外冠状动脉介入治疗（经皮冠状动脉介入治疗或冠状动脉旁路移植术）。
如果 T1 加权成像和冠状动脉磁共振血管造影术联合应用有助于评估 CKD 患者的 CAD 风险，那么这项研究将对管理 CAD 高危 CKD 患者具有重要的临床意义。
日本临床试验注册中心（jRCT）1052210075。注册于 2021 年 9 月 10 日。
