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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Arterial Diseases | Study protocol

Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial

Authors: Teruo Noguchi, Hideki Ota, Naoya Matsumoto, Yoshiaki Morita, Akira Oshita, Eiji Kawasaki, Tomohiro Kawasaki, Kensuke Moriwaki, Shingo Kato, Kazuki Fukui, Tomoya Hoshi, Hiroaki Watabe, Tomoaki Kanaya, Yasuhide Asaumi, Yu Kataoka, Fumiyuki Otsuka, Kensuke Takagi, Shuichi Yoneda, Kenichiro Sawada, Takamasa Iwai, Hideo Matama, Satoshi Honda, Masashi Fujino, Hiroyuki Miura, Kunihiro Nishimura, Kei Takase

Published in: Trials | Issue 1/2022

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Abstract

Background

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.

Methods

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).

Discussion

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.

Trial registration

Japan Registry of Clinical Trials (jRCT) 1,052,210,075. Registered on September 10, 2021.
Appendix
Available only for authorised users
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Metadata
Title
Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial
Authors
Teruo Noguchi
Hideki Ota
Naoya Matsumoto
Yoshiaki Morita
Akira Oshita
Eiji Kawasaki
Tomohiro Kawasaki
Kensuke Moriwaki
Shingo Kato
Kazuki Fukui
Tomoya Hoshi
Hiroaki Watabe
Tomoaki Kanaya
Yasuhide Asaumi
Yu Kataoka
Fumiyuki Otsuka
Kensuke Takagi
Shuichi Yoneda
Kenichiro Sawada
Takamasa Iwai
Hideo Matama
Satoshi Honda
Masashi Fujino
Hiroyuki Miura
Kunihiro Nishimura
Kei Takase
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06820-w

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