Laake Kristian, Myhre Peder, Nordby Linn M, Seljeflot Ingebjørg, Abdelnoor Michael, Smith Pål, Tveit Arnljot, Arnesen Harald, Solheim Svein
Center for Clinical Heart Research, Oslo University Hospital, Ullevål, Oslo, Norway.
BMC Geriatr. 2014 Jun 13;14:74. doi: 10.1186/1471-2318-14-74.
Both epidemiological and randomized clinical studies suggest that supplementation with very-long-chain marine polyunsaturated n-3 fatty acids (n-3 PUFA) have cardioprotective effects, however these results are not without controversy. Study population, sample-size, type of supplementation and type of endpoint have all varied widely accross different studies.Therefore, the aims of the present study are to evaluate the effect of 2 years supplementation with capsules of very-long chain marine n-3 PUFA on top of standard therapy in elderly patients after acute myocardial infarction (AMI).In addition, special characteristics of this population with regard to prediction of clinical outcome will be investigated. The hypothesis is that this supplementation on top of modern therapy will reduce the occurence of major cardiovascular events (MACE). We present the design of the OMEMI (OMega-3 fatty acids in Elderly patients with Myocardial Infarction) study.
METHODS/DESIGN: The OMEMI study is designed as a randomized, placebo-controlled double-blind multicenter trial.Included are patients ≥70-82 years of age who have sustained AMI. Patients of either gender are eligible. Sample size calculation based on existing literature has resulted in the need for 1400 patients followed for 2 years, based on the assumption that the n-3 PUFA supplementation will reduce MACE with 30%. The study medication is Pikasol® Axellus AS, Norway, 3 capsules (1.8 g eicosapentaenoic acid (EPA) + docohexaenoic acid (DHA)) per day, and matching placebo is corn oil. The Primary end-point is the composite of total mortality, first non-fatal recurring AMI, stroke and revascularization. Secondary end-point is the occurrence of new onset atrial fibrillation. Extensive biobanking will be performed, including adipose tissue biopsies. Compliance will be assessed by measurements of the fatty acid profile in serum, sampled at inclusion, after 12 months and at the end of study.
The OMEMI study is scheduled to terminate when the last included patient has been followed for 2 years. To the best of our knowledge, the OMEMI study is the first to evaluate the effect of n-3 PUFAs on CVDs and mortality in a high risk elderly population having suffered an acute myocardial infarction.
ClinicalTrials.gov, NCT01841944.
流行病学研究和随机临床试验均表明，补充超长链海洋多不饱和n-3脂肪酸（n-3 PUFA）具有心脏保护作用，但这些结果并非毫无争议。不同研究中的研究人群、样本量、补充类型和终点类型差异很大。因此，本研究的目的是评估在标准治疗基础上，给予老年急性心肌梗死（AMI）患者2年超长链海洋n-3 PUFA胶囊补充剂的效果。此外，还将研究该人群在临床结局预测方面的特殊特征。假设是在现代治疗基础上进行这种补充将减少主要心血管事件（MACE）的发生。我们介绍了OMEMI（老年心肌梗死患者的ω-3脂肪酸）研究的设计。
方法/设计：OMEMI研究设计为一项随机、安慰剂对照、双盲多中心试验。纳入年龄≥70 - 82岁且发生过AMI的患者。男女患者均符合条件。根据现有文献进行样本量计算，假设n-3 PUFA补充剂可使MACE降低30%，则需要1400例患者随访2年。研究药物为挪威Axellus AS公司生产的Pikasol®，每天3粒胶囊（含1.8克二十碳五烯酸（EPA）+二十二碳六烯酸（DHA）），匹配的安慰剂为玉米油。主要终点是全因死亡率、首次非致命复发性AMI、中风和血运重建的复合终点。次要终点是新发房颤的发生。将进行广泛的生物样本库建设，包括脂肪组织活检。通过在入组时、12个月后和研究结束时采集血清测量脂肪酸谱来评估依从性。
OMEMI研究计划在最后一名纳入患者随访2年后结束。据我们所知，OMEMI研究是首个评估n-3 PUFA对急性心肌梗死高危老年人群心血管疾病和死亡率影响的研究。
ClinicalTrials.gov，NCT01841944。
