Department of Cardiology, Hospital General Universitario Gregorio Marañón, Facultad de Medicina, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria Gregorio Marañón, and CIBERCV, Madrid, Spain.
Department of Preventive Medicine and Public Health, University of Navarra, IDISNA, CIBEROBN, Pamplona, Spain.
Trials. 2021 Nov 12;22(1):795. doi: 10.1186/s13063-021-05746-z.
Primary prevention trials have demonstrated that the traditional Mediterranean diet is associated with a reduction in cardiovascular mortality and morbidity. However, this benefit has not been proven for secondary prevention after an acute coronary syndrome (ACS). We hypothesized that a high-intensity Mediterranean diet intervention after an ACS decreases the vulnerability of atherosclerotic plaques by complex interactions between anti-inflammatory effects, microbiota changes and modulation of gene expression.
The MEDIMACS project is an academically funded, prospective, randomized, controlled and mechanistic clinical trial designed to address the effects of an active randomized intervention with the Mediterranean diet on atherosclerotic plaque vulnerability, coronary endothelial dysfunction and other mechanistic endpoints. One hundred patients with ACS are randomized 1:1 to a monitored high-intensity Mediterranean diet intervention or to a standard-of-care arm. Adherence to diet is assessed in both arms using food frequency questionnaires and biomarkers of compliance. The primary endpoint is the change (from baseline to 12 months) in the thickness of the fibrous cap of a non-significant atherosclerotic plaque in a non-culprit vessel, as assessed by repeated optical coherence tomography intracoronary imaging. Indices of coronary vascular physiology and changes in gastrointestinal microbiota, immunological status and protein and metabolite profiles will be evaluated as secondary endpoints.
The results of this trial will address the key effects of dietary habits on atherosclerotic risk and will provide initial data on the complex interplay of immunological, microbiome-, proteome- and metabolome-related mechanisms by which non-pharmacological factors may impact the progression of coronary atherosclerosis after an ACS.
ClinicalTrials.gov NCT03842319 . Registered on 13 May 2019.
初级预防试验已经证明，传统的地中海饮食与降低心血管死亡率和发病率有关。然而，这种益处尚未在急性冠状动脉综合征（ACS）后的二级预防中得到证明。我们假设 ACS 后高强度地中海饮食干预通过抗炎作用、微生物群变化和基因表达调节之间的复杂相互作用，降低动脉粥样硬化斑块的脆弱性。
MEDIMACS 项目是一项由学术机构资助的、前瞻性的、随机的、对照的和机制性临床试验，旨在研究地中海饮食的积极随机干预对动脉粥样硬化斑块脆弱性、冠状动脉内皮功能障碍和其他机制终点的影响。100 名 ACS 患者以 1:1 的比例随机分为强化地中海饮食干预组或标准护理组。通过食物频率问卷和依从性生物标志物评估两组的饮食依从性。主要终点是在非罪犯血管中，通过重复光学相干断层扫描冠状动脉内成像评估非显著动脉粥样硬化斑块纤维帽厚度的变化（从基线到 12 个月）。将评估冠状动脉血管生理学的变化和胃肠道微生物群、免疫状态以及蛋白质和代谢物谱的变化作为次要终点。
该试验的结果将解决饮食习惯对动脉粥样硬化风险的关键影响，并提供关于非药物因素如何通过免疫、微生物组、蛋白质组和代谢组相关机制影响 ACS 后冠状动脉粥样硬化进展的复杂相互作用的初步数据。
ClinicalTrials.gov NCT03842319. 于 2019 年 5 月 13 日注册。
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