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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
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
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:https://​doi.​org/​10.​1186/​s13063-017-2353-1) contains supplementary material, which is available to authorized users.

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.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 119 kb)
13063_2017_2353_MOESM1_ESM.doc
Literatur
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