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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

Tracking Information
First Submitted Date  ICMJE June 18, 2009
First Posted Date  ICMJE June 19, 2009
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2021)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2009)		 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. [ Time Frame: Five Years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2021)
  • 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
  • Concentration of LDL cholesterol. [ Time Frame: Seven Years ]
    Concentration of LDL cholesterol in blood samples
  • 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
  • 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
  • Blood pressure. [ Time Frame: Seven Years ]
    Study of blood pressure in response to the study
  • Incidence of malignancy. [ Time Frame: Seven Years ]
    Appearance of malignancy
  • Progression of Cognitive Decline. [ Time Frame: Seven Years ]
    Cognitive decline will be evaluated by validated questionnaires
  • 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.
  • Extended composite of heart events [ Time Frame: Seven Years ]
    Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
  • Incidence of type 2 Diabetes Mellitus [ Time Frame: Up to Seven Years ]
    Incidence of type 2 Diabetes Mellitus during the study
  • 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
  • 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.
  • Arrhythmias [ Time Frame: Up to Seven Years ]
    Study of relationship between existing or new Arrhythmias on clinical events
  • 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
  • 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.
  • 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
  • Gene Expression [ Time Frame: Up to Seven Years ]
    Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
  • 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
  • AGEs [ Time Frame: Up to Seven Years ]
    Metabolism of advanced glycation end products.
  • Mineral metabolism [ Time Frame: Up to Seven Years ]
    Impact of mineral metabolism on atherosclerosis
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2009)
  • Incidence of intermittent claudication. [ Time Frame: Five years ]
  • Concentration of LDL cholesterol. [ Time Frame: Five years ]
  • Atherogenic ratio Total cholesterol/HDL and LDL/HDL. [ Time Frame: Five Years ]
  • Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose). [ Time Frame: Five Years ]
  • Blood pressure. [ Time Frame: Five Years ]
  • Response to ergometry tests. [ Time Frame: Five Years ]
  • Incidence of malignancy. [ Time Frame: Five Years ]
  • Progression of Cognitive Decline. [ Time Frame: Five Years ]
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2021)
  • 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
  • genetics, genomics and epigenetics [ Time Frame: Up to seven years ]
    Influence of genetic data in the development clinical outcomes
  • postprandial lipaemia [ Time Frame: Up to seven years ]
    Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
Official Title  ICMJE Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Myocardial Infarction
  • Unstable Angina
  • Malignancy
  • Cognitive Decline
  • Diabetes Mellitus
  • Metabolic Syndrome
Intervention  ICMJE
  • Behavioral: Mediterranean Diet
    Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
  • Behavioral: Low Fat Diet
    Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Study Arms  ICMJE
  • 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)
    Intervention: Behavioral: Low Fat Diet
  • Experimental: Mediterranean Diet
    Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
    Intervention: Behavioral: Mediterranean Diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2015)		 1002
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2009)		 874
Actual Study Completion Date  ICMJE May 2021
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00924937
Other Study ID Numbers  ICMJE CORDIOPREV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Francisco Perez Jimenez, Hospital Universitario Reina Sofia de Cordoba
Original Responsible Party Francisco Perez Jimenez, Reina Sofia University Hospital
Current Study Sponsor  ICMJE Hospital Universitario Reina Sofia de Cordoba
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco Perez-Jimenez, MD,PhD Reina Sofia University Hospital
PRS Account Hospital Universitario Reina Sofia de Cordoba
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP