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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00924937
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Francisco Perez Jimenez, Hospital Universitario Reina Sofia de Cordoba

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Unstable Angina Malignancy Cognitive Decline Diabetes Mellitus Metabolic Syndrome Behavioral: Mediterranean Diet Behavioral: Low Fat Diet Not Applicable

Detailed Description:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : November 2009
Actual Primary Completion Date : July 2018
Actual Study Completion Date : May 2021
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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)
 Behavioral: Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Experimental: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
 Behavioral: Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function


Other Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924937


Locations
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Spain
Reina Sofia University Hospital
Cordoba, Spain, 14001
Sponsors and Collaborators
Hospital Universitario Reina Sofia de Cordoba
Investigators
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Principal Investigator: Francisco Perez-Jimenez, MD,PhD Reina Sofia University Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francisco Perez Jimenez, Chief of Internal Medicine Unit, Hospital Universitario Reina Sofia de Cordoba
ClinicalTrials.gov Identifier: NCT00924937    
Other Study ID Numbers: CORDIOPREV
First Posted: June 19, 2009    Key Record Dates
Last Update Posted: June 3, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francisco Perez Jimenez, Hospital Universitario Reina Sofia de Cordoba:
Cardiovascular events
Blood pressure
Incidence of Cancer
Cognitive decline
 Mediterranean Diet
Secondary Prevention
Low fat diet
Additional relevant MeSH terms:
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Myocardial Infarction
Angina, Unstable
Metabolic Syndrome
Infarction
Cognitive Dysfunction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations