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Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effect of eicosapentaenoic acid/docosahexaenoic acid on coronary high-intensity plaques detected with non-contrast T1-weighted imaging (the AQUAMARINE EPA/DHA study): study protocol for a randomized controlled trial

Authors: Kazuhiro Nakao, Teruo Noguchi, Yasuhide Asaumi, Yoshiaki Morita, Tomoaki Kanaya, Masashi Fujino, Hayato Hosoda, Shuichi Yoneda, Shoji Kawakami, Toshiyuki Nagai, Kensaku Nishihira, Takahiro Nakashima, Reon Kumasaka, Tetsuo Arakawa, Fumiyuki Otsuka, Michio Nakanishi, Yu Kataoka, Yoshio Tahara, Yoichi Goto, Haruko Yamamoto, Toshimitsu Hamasaki, Satoshi Yasuda

Published in: Trials | Issue 1/2018

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Abstract

Background

Despite the success of HMG-CoA reductase inhibitor (statin) therapy in reducing atherosclerotic cardiovascular events, a residual risk for cardiovascular events in patients with coronary artery disease (CAD) remains. Long-chain n-3 polyunsaturated fatty acids (LC n-3 PUFAs), especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are promising anti-atherosclerosis agents that might reduce the residual CAD risk. Non-contrast T1-weighted imaging (T1WI) with cardiac magnetic resonance (CMR) less invasively identifies high-risk coronary plaques as high-intensity signals. These high-intensity plaques (HIPs) are quantitatively assessed using the plaque-to-myocardium signal intensity ratio (PMR). Our goal is to assess the effect of EPA/DHA on coronary HIPs detected with T1WI in patients with CAD on statin treatment.

Methods/design

This prospective, controlled, randomized, open-label study examines the effect of 12 months of EPA/DHA therapy and statin treatment on PMR of HIPs detected with CMR and computed tomography angiography (CTA) in patients with CAD. The primary endpoint is the change in PMR after EPA/DHA treatment. Secondary endpoints include changes in Hounsfield units, plaque volume, vessel area, and plaque area measured using CTA. Subjects are randomly assigned to either of three groups: the 2 g/day EPA/DHA group, the 4 g/day EPA/DHA group, or the no-treatment group.

Discussion

This trial will help assess whether EPA/DHA has an anti-atherosclerotic effect using PMR of HIPs detected by CMR. The trial outcomes will provide novel insights into the effect of EPA/DHA on high-risk coronary plaques and may provide new strategies for lowering the residual risk in patients with CAD on statin therapy.

Trial registration

The University Hospital Medical Information Network (UMIN) Clinical Trials Registry, ID: UMIN000015316. Registered on 2 October 2014.
Appendix
Available only for authorised users
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Metadata
Title
Effect of eicosapentaenoic acid/docosahexaenoic acid on coronary high-intensity plaques detected with non-contrast T1-weighted imaging (the AQUAMARINE EPA/DHA study): study protocol for a randomized controlled trial
Authors
Kazuhiro Nakao
Teruo Noguchi
Yasuhide Asaumi
Yoshiaki Morita
Tomoaki Kanaya
Masashi Fujino
Hayato Hosoda
Shuichi Yoneda
Shoji Kawakami
Toshiyuki Nagai
Kensaku Nishihira
Takahiro Nakashima
Reon Kumasaka
Tetsuo Arakawa
Fumiyuki Otsuka
Michio Nakanishi
Yu Kataoka
Yoshio Tahara
Yoichi Goto
Haruko Yamamoto
Toshimitsu Hamasaki
Satoshi Yasuda
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2353-1

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