JPRN-jRCTs051180125已完成未知
Effect of Eicosapentaenoic acid/Docosahexaenoic acid on Coronary High-intensity Plaques Detected with Non-contrast T1-Weighted Imaging - The AQUAMARINE EPA/DHA Study
Yasuda Satosi0 个研究点目标入组 84 人开始时间: 2019年3月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 84
研究概览
简要总结
The effect of 1-year administration of omega-3 fatty acid (2 doses) on PMR of coronary high risk plaques evaluated by cardiac MRI was not verified compared to no treatment group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following criteria.
- •1.Diagnosed with hyperlipidemia and receiving instructions for lifestyle modification
- •2.Diagnosed with coronary artery disease and have coronary stenosis exceeding 25%, as measured by computed tomography angiography (CTA) or invasive coronary angiography (CAG).
- •3.Have been taking an HMG-CoA reductase inhibitor at a fixed dose and administration method from at least 4 weeks before informed consent
- •4.Have at least one coronary plaque with a plaque to myocardium ratio (PMR) of 1.0 or more in non-contrast T1-weighted cardiac magnetic resonance (CMR) imaging at the screening test
- •5.Serum LDL-cholesterol level less than 100 mg/dL at the screening test
- •6.Age less than 20 years at the time of consent
- •7.Capable of visiting the study centers on an outpatient basis
- •8.Capable of providing written consent before participation in this study
排除标准
- •1.Use of EPA preparation within 12 weeks before informed consent
- •2.Scheduled to undergo percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) during the observation period
- •3.Presence of type 1 diabetes mellitus or type 2 diabetes mellitus with uncontrolled hyperglycemia (HbA1C more than 8.0%)
- •4.Clinically apparent impairment of renal function
- •5.Presence of bleeding (e.g., hemophilia, capillary fragility, gastrointestinal tract ulcer, urinary tract bleeding, hemoptysis, vitreous hemorrhage)
- •6.History of hypersensitivity to any component of the investigational product
- •7.Other patients who are inappropriate for participation in this study in the opinion of the principal investigator or investigator.
研究者
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