Back to resultsCORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)
Primary Purpose
Myocardial Infarction, Unstable Angina, Malignancy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mediterranean Diet
Low Fat Diet
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Infarction focused on measuring Cardiovascular events, Blood pressure, Incidence of Cancer, Cognitive decline, Mediterranean Diet, Secondary Prevention, Low fat diet
Eligibility 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).
Sites / Locations
- Reina Sofia University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low Fat Diet
Mediterranean Diet
Arm Description
Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids)
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Outcomes
Primary Outcome Measures
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.
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
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Data from clinical and/or diagnostic tests will be analyzed
Concentration of LDL cholesterol.
Concentration of LDL cholesterol in blood samples
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
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).
Study of the metabolism of carbohydrates during the trial
Blood pressure.
Study of blood pressure in response to the study
Incidence of malignancy.
Appearance of malignancy
Progression of Cognitive Decline.
Cognitive decline will be evaluated by validated questionnaires
Extended composite of cardiovascular disease progression
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
Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
Incidence of type 2 Diabetes Mellitus
Incidence of type 2 Diabetes Mellitus during the study
Anthropometric changes. Metabolic disease
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
Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
Arrhythmias
Study of relationship between existing or new Arrhythmias on clinical events
Individual evaluation of all components of the primary outcome.
Individual apparition of hard cardiovascular events:
myocardial infarction
revascularization
ischemic stroke
documented peripheral artery disease
cardiovascular death
Global Metabolomics
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
Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
Gene Expression
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
Inflammation and oxidative stress
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
AGEs
Metabolism of advanced glycation end products.
Mineral metabolism
Impact of mineral metabolism on atherosclerosis
Echographic markers of cardiac function and clinical outcomes
Cardiac function studies by Echocardiography at baseline and during the study
Microparticles
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
27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Full Information
NCT ID
NCT00924937
First Posted
June 18, 2009
Last Updated
May 31, 2021
Sponsor
Hospital Universitario Reina Sofia de Cordoba
1. Study Identification
Unique Protocol Identification Number
NCT00924937
Brief Title
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
Acronym
CORDIOPREV
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2009 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
May 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Reina Sofia de Cordoba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Unstable Angina, Malignancy, Cognitive Decline, Diabetes Mellitus, Metabolic Syndrome
Keywords
Cardiovascular events, Blood pressure, Incidence of Cancer, Cognitive decline, Mediterranean Diet, Secondary Prevention, Low fat diet
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1002 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Fat Diet
Arm Type
Active Comparator
Arm Description
Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids)
Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean Diet
Intervention Description
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
Intervention Type
Behavioral
Intervention Name(s)
Low Fat Diet
Intervention Description
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Primary Outcome Measure Information:
Title
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.
Description
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
Secondary Outcome Measure Information:
Title
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Description
Data from clinical and/or diagnostic tests will be analyzed
Time Frame
Seven Years
Title
Concentration of LDL cholesterol.
Description
Concentration of LDL cholesterol in blood samples
Time Frame
Seven Years
Title
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
Description
Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
Time Frame
Seven Years
Title
Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).
Description
Study of the metabolism of carbohydrates during the trial
Time Frame
Seven Years
Title
Blood pressure.
Description
Study of blood pressure in response to the study
Time Frame
Seven Years
Title
Incidence of malignancy.
Description
Appearance of malignancy
Time Frame
Seven Years
Title
Progression of Cognitive Decline.
Description
Cognitive decline will be evaluated by validated questionnaires
Time Frame
Seven Years
Title
Extended composite of cardiovascular disease progression
Description
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
Seven Years
Title
Extended composite of heart events
Description
Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
Time Frame
Seven Years
Title
Incidence of type 2 Diabetes Mellitus
Description
Incidence of type 2 Diabetes Mellitus during the study
Time Frame
Up to Seven Years
Title
Anthropometric changes. Metabolic disease
Description
Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study
Time Frame
Up to Seven Years
Title
Gut Microbiota
Description
Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
Time Frame
Up to Seven Years
Title
Arrhythmias
Description
Study of relationship between existing or new Arrhythmias on clinical events
Time Frame
Up to Seven Years
Title
Individual evaluation of all components of the primary outcome.
Description
Individual apparition of hard cardiovascular events:
myocardial infarction
revascularization
ischemic stroke
documented peripheral artery disease
cardiovascular death
Time Frame
Up to Seven Years
Title
Global Metabolomics
Description
Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.
Time Frame
Up to Seven Years
Title
Specific metabolomics
Description
Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
Time Frame
Up to Seven Years
Title
Gene Expression
Description
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
Time Frame
Up to Seven Years
Title
Inflammation and oxidative stress
Description
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
Time Frame
Up to Seven Years
Title
AGEs
Description
Metabolism of advanced glycation end products.
Time Frame
Up to Seven Years
Title
Mineral metabolism
Description
Impact of mineral metabolism on atherosclerosis
Time Frame
Up to Seven Years
Title
Echographic markers of cardiac function and clinical outcomes
Description
Cardiac function studies by Echocardiography at baseline and during the study
Time Frame
Up to Seven Years
Title
Microparticles
Description
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
Time Frame
Up to Seven Years
Title
Subgroup analysis
Description
27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Time Frame
Up to Seven Years
Other Pre-specified Outcome Measures:
Title
Endothelial function (Flow mediated dilation)
Description
Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed
Time Frame
Up to Seven Years
Title
genetics, genomics and epigenetics
Description
Influence of genetic data in the development clinical outcomes
Time Frame
Up to seven years
Title
postprandial lipaemia
Description
Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables
Time Frame
Up to seven years
Title
Study of other Clinical events
Description
Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease
Time Frame
Up to seven years
Title
Subgroup Studies
Description
Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Time Frame
Up to seven years
Title
Further Studies
Description
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
Time Frame
Up to Seven Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Perez-Jimenez, MD,PhD
Organizational Affiliation
Reina Sofia University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reina Sofia University Hospital
City
Cordoba
ZIP/Postal Code
14001
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Talavera-Garcia E, Delgado-Lista J, Garcia-Rios A, Delgado-Casado N, Gomez-Luna P, Gomez-Garduno A, Gomez-Delgado F, Alcala-Diaz JF, Yubero-Serrano E, Marin C, Perez-Caballero AI, Fuentes-Jimenez FJ, Camargo A, Rodriguez-Cantalejo F, Tinahones FJ, Ordovas JM, Perez-Jimenez F, Perez-Martinez P, Lopez-Miranda J. Influence of Obesity and Metabolic Disease on Carotid Atherosclerosis in Patients with Coronary Artery Disease (CordioPrev Study). PLoS One. 2016 Apr 11;11(4):e0153096. doi: 10.1371/journal.pone.0153096. eCollection 2016. Erratum In: PLoS One. 2016;11(6):e0157213.
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PubMed Identifier
26505825
Citation
Haro C, Montes-Borrego M, Rangel-Zuniga OA, Alcala-Diaz JF, Gomez-Delgado F, Perez-Martinez P, Delgado-Lista J, Quintana-Navarro GM, Tinahones FJ, Landa BB, Lopez-Miranda J, Camargo A, Perez-Jimenez F. Two Healthy Diets Modulate Gut Microbial Community Improving Insulin Sensitivity in a Human Obese Population. J Clin Endocrinol Metab. 2016 Jan;101(1):233-42. doi: 10.1210/jc.2015-3351. Epub 2015 Oct 27.
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PubMed Identifier
26474775
Citation
Blanco-Rojo R, Alcala-Diaz JF, Wopereis S, Perez-Martinez P, Quintana-Navarro GM, Marin C, Ordovas JM, van Ommen B, Perez-Jimenez F, Delgado-Lista J, Lopez-Miranda J. The insulin resistance phenotype (muscle or liver) interacts with the type of diet to determine changes in disposition index after 2 years of intervention: the CORDIOPREV-DIAB randomised clinical trial. Diabetologia. 2016 Jan;59(1):67-76. doi: 10.1007/s00125-015-3776-4. Epub 2015 Oct 16.
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derived
PubMed Identifier
25231836
Citation
Perez-Martinez P, Alcala-Diaz JF, Delgado-Lista J, Garcia-Rios A, Gomez-Delgado F, Marin-Hinojosa C, Rodriguez-Cantalejo F, Delgado-Casado N, Perez-Caballero AI, Fuentes-Jimenez FJ, Camargo A, Tinahones FJ, Ordovas JM, Perez-Jimenez F, Lopez-Miranda J. Metabolic phenotypes of obesity influence triglyceride and inflammation homoeostasis. Eur J Clin Invest. 2014 Nov;44(11):1053-64. doi: 10.1111/eci.12339.
Results Reference
derived
Links:
URL
http://www.cordioprev.es/index.php/en/
Description
Webpage of the study
Learn more about this trial
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
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