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CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)

2021年5月31日 更新者：Francisco Perez Jimenez、Hospital Universitario Reina Sofia de Cordoba

Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease

The purpose of this study is to compare the effects of the consumption of two different dietary patterns (low fat versus Mediterranean Diet) on the incidence of cardiovascular events of persons with coronary disease.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Randomized clinical trial involving 1002 patients with coronary disease that are undergoing one of two diets in a randomized design (two groups; Mediterranean Diet 502 patients, Low Fat 500 patients) for 7 years. The two diets are: a)Low fat diet: <30% fat (12-14% monounsaturated fatty acids (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% MUFA; 6% PUFA ; <10% SAT).

Primary Objective:

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).

Secondary Objectives:

Those related in the Outcome Measures section of this webpage

研究类型

介入性

注册 (实际的)

1002

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 西班牙
      • Cordoba、西班牙、14001
        • Reina Sofia University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Informed Consent

  • Clinical: Unstable coronary disease with documented vessel/myocardial damage

    • Acute Myocardial Infarction
    • Revascularization

Exclusion Criteria:

  • Age < 20 or > 75 years (or life expectancy lower than 5 years).
  • Patients already planned for revascularization.
  • Patients submitted to revascularization in the last 6 months
  • Grade II-IV Heart failure.
  • Left ventricle dysfunction with ejection fraction lower than 35%.
  • Patients unable to follow a protocol.
  • Patients with severe uncontrol of Diabetes Mellitus, or those with Renal Insufficiency with plasma creatinine higher than 2mg/dl, or cerebral complications of Diabetes mellitus.

  • Other chronic diseases:

    • Psychiatric diseases
    • Renal Insufficiency
    • Chronic Hepatopathy
    • Active Malignancy
    • Chronic obstructive pulmonary disease
    • Diseases of the digestive tract Endocrine disorders
  • Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Low Fat Diet
Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids)
行为的：Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
实验性的：Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
行为的：Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.
大体时间：Seven Years
Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death) after a median follow-up of 7 years.
Seven Years

次要结果测量

结果测量
措施说明
大体时间
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
大体时间：Seven Years
Data from clinical and/or diagnostic tests will be analyzed
Seven Years
Concentration of LDL cholesterol.
大体时间：Seven Years
Concentration of LDL cholesterol in blood samples
Seven Years
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
大体时间：Seven Years
Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
Seven Years
Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).
大体时间：Seven Years
Study of the metabolism of carbohydrates during the trial
Seven Years
Blood pressure.
大体时间：Seven Years
Study of blood pressure in response to the study
Seven Years
Incidence of malignancy.
大体时间：Seven Years
Appearance of malignancy
Seven Years
Progression of Cognitive Decline.
大体时间：Seven Years
Cognitive decline will be evaluated by validated questionnaires
Seven Years
Extended composite of cardiovascular disease progression
大体时间：Seven Years
Incidence of cardiac death, myocardial infarction, angina event, coronary revascularization or cardiac transplant, stroke, symptomatic heart failure, or any other clinical manifestation of cardiovascular event.
Seven Years
Extended composite of heart events
大体时间：Seven Years
Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
Seven Years
Incidence of type 2 Diabetes Mellitus
大体时间：Up to Seven Years
Incidence of type 2 Diabetes Mellitus during the study
Up to Seven Years
Anthropometric changes. Metabolic disease
大体时间：Up to Seven Years
Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study
Up to Seven Years
Gut Microbiota
大体时间：Up to Seven Years
Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
Up to Seven Years
Arrhythmias
大体时间：Up to Seven Years
Study of relationship between existing or new Arrhythmias on clinical events
Up to Seven Years
Individual evaluation of all components of the primary outcome.
大体时间：Up to Seven Years

Individual apparition of hard cardiovascular events:

  • myocardial infarction
  • revascularization
  • ischemic stroke
  • documented peripheral artery disease
  • cardiovascular death
Up to Seven Years
Global Metabolomics
大体时间：Up to Seven Years
Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.
Up to Seven Years
Specific metabolomics
大体时间：Up to Seven Years
Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
Up to Seven Years
Gene Expression
大体时间：Up to Seven Years
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
Up to Seven Years
Inflammation and oxidative stress
大体时间：Up to Seven Years
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
Up to Seven Years
AGEs
大体时间：Up to Seven Years
Metabolism of advanced glycation end products.
Up to Seven Years
Mineral metabolism
大体时间：Up to Seven Years
Impact of mineral metabolism on atherosclerosis
Up to Seven Years
Echographic markers of cardiac function and clinical outcomes
大体时间：Up to Seven Years
Cardiac function studies by Echocardiography at baseline and during the study
Up to Seven Years
Microparticles
大体时间：Up to Seven Years
Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury). The quantification of the EPCs and EMPs will be performed by flow cytometry
Up to Seven Years
Subgroup analysis
大体时间：Up to Seven Years
27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Up to Seven Years

其他结果措施

结果测量
措施说明
大体时间
Endothelial function (Flow mediated dilation)
大体时间：Up to Seven Years
Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed
Up to Seven Years
genetics, genomics and epigenetics
大体时间：Up to seven years
Influence of genetic data in the development clinical outcomes
Up to seven years
postprandial lipaemia
大体时间：Up to seven years
Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables
Up to seven years
Study of other Clinical events
大体时间：Up to seven years
Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease
Up to seven years
Subgroup Studies
大体时间：Up to seven years
Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Up to seven years
Further Studies
大体时间：Up to Seven Years
Additional secondary objectives will be carried out in light of current and/or future knowledge of ischemic heart disease risk factors, prognostic factors and pathophysiological pathways, and will include, but not be limited to, endothelial function, inflammation, cell biology, molecular biology, proteomics, genetics and epigenetics
Up to Seven Years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospital Universitario Reina Sofia de Cordoba

调查人员

  • 首席研究员：Francisco Perez-Jimenez, MD,PhD、Reina Sofia University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2009年11月1日

初级完成 (实际的)

2018年7月1日

研究完成 (实际的)

2021年5月1日

研究注册日期

首次提交

2009年6月18日

首先提交符合 QC 标准的

2009年6月18日

首次发布 (估计)

2009年6月19日

研究记录更新

最后更新发布 (实际的)

2021年6月3日

上次提交的符合 QC 标准的更新

2021年5月31日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CORDIOPREV

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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