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Completed

NCT Number: NCT00924937

CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mediterranean Diet

Behavioral

Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

Low Fat Diet

Behavioral

Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)

Primary outcomes

  1. 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.

    Time frame: 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.

Secondary outcomes

  1. Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.

    Time frame: Seven Years

    Data from clinical and/or diagnostic tests will be analyzed

  2. Concentration of LDL cholesterol.

    Time frame: Seven Years

    Concentration of LDL cholesterol in blood samples

  3. Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.

    Time frame: Seven Years

    Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study

  4. Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).

    Time frame: Seven Years

    Study of the metabolism of carbohydrates during the trial

  5. Blood pressure.

    Time frame: Seven Years

    Study of blood pressure in response to the study

  6. Incidence of malignancy.

    Time frame: Seven Years

    Appearance of malignancy

  7. Progression of Cognitive Decline.

    Time frame: Seven Years

    Cognitive decline will be evaluated by validated questionnaires

  8. Extended composite of cardiovascular disease progression

    Time frame: 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.

  9. Extended composite of heart events

    Time frame: Seven Years

    Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest

  10. Incidence of type 2 Diabetes Mellitus

    Time frame: Up to Seven Years

    Incidence of type 2 Diabetes Mellitus during the study

  11. Anthropometric changes. Metabolic disease

    Time frame: 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

  12. Gut Microbiota

    Time frame: 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.

  13. Arrhythmias

    Time frame: Up to Seven Years

    Study of relationship between existing or new Arrhythmias on clinical events

  14. Individual evaluation of all components of the primary outcome.

    Time frame: Up to Seven Years

    Individual apparition of hard cardiovascular events:

    • myocardial infarction
    • revascularization
    • ischemic stroke
    • documented peripheral artery disease
    • cardiovascular death
  15. Global Metabolomics

    Time frame: 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.

  16. Specific metabolomics

    Time frame: Up to Seven Years

    Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc

  17. Gene Expression

    Time frame: Up to Seven Years

    Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc

  18. Inflammation and oxidative stress

    Time frame: Up to Seven Years

    Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied

  19. AGEs

    Time frame: Up to Seven Years

    Metabolism of advanced glycation end products.

  20. Mineral metabolism

    Time frame: Up to Seven Years

    Impact of mineral metabolism on atherosclerosis

  21. Echographic markers of cardiac function and clinical outcomes

    Time frame: Up to Seven Years

    Cardiac function studies by Echocardiography at baseline and during the study

  22. Microparticles

    Time frame: 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

  23. Subgroup analysis

    Time frame: Up to Seven Years

    • Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

Other outcomes

  1. Endothelial function (Flow mediated dilation)

    Time frame: 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

  2. genetics, genomics and epigenetics

    Time frame: Up to seven years

    Influence of genetic data in the development clinical outcomes

  3. postprandial lipaemia

    Time frame: Up to seven years

    Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables

  4. Study of other Clinical events

    Time frame: 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

  5. Subgroup Studies

    Time frame: Up to seven years

    Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function

  6. Further Studies

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Reina Sofia de Cordoba

Other Gov

Registry information

Official study title

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

Acronym: CORDIOPREV

Important dates

Study start
2009
Primary completion
2018
Study completion
2021
First posted
Jun 19, 2009
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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