CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Hospital Universitario Reina Sofia de Cordoba1,002 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

1,002

Conditions

Myocardial Infarction Unstable Angina Malignancy Cognitive Decline Diabetes Mellitus Metabolic Syndrome

Interventions

Mediterranean DietBEHAVIORAL

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

Low Fat DietBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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).

Locations (1)

Reina Sofia University Hospital

Córdoba, Spain

Outcomes

Primary Outcomes

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 Outcomes

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

Data from clinical and/or diagnostic tests will be analyzed

Time frame: Seven Years

Concentration of LDL cholesterol.

Concentration of LDL cholesterol in blood samples

Time frame: Seven Years

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

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

Time frame: Seven Years

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

Time frame: Seven Years

Blood pressure.

Study of blood pressure in response to the study

Time frame: Seven Years

Incidence of malignancy.

Appearance of malignancy

Time frame: Seven Years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Progression of Cognitive Decline.

Cognitive decline will be evaluated by validated questionnaires

Time frame: Seven Years

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.

Time frame: Seven Years

Extended composite of heart events

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

Time frame: Seven Years

Incidence of type 2 Diabetes Mellitus

Incidence of type 2 Diabetes Mellitus during the study

Time frame: Up to Seven Years

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

Time frame: Up to Seven Years

Gut Microbiota

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

Arrhythmias

Study of relationship between existing or new Arrhythmias on clinical events

Time frame: Up to Seven Years

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

Time frame: Up to Seven Years

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.

Time frame: Up to Seven Years

Specific metabolomics

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

Time frame: Up to Seven Years

Gene Expression

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

Time frame: Up to Seven Years

Inflammation and oxidative stress

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

Time frame: Up to Seven Years

AGEs

Metabolism of advanced glycation end products.

Time frame: Up to Seven Years

Mineral metabolism

Impact of mineral metabolism on atherosclerosis

Time frame: Up to Seven Years

Echographic markers of cardiac function and clinical outcomes

Cardiac function studies by Echocardiography at baseline and during the study

Time frame: Up to Seven Years

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

Time frame: Up to Seven Years

Subgroup analysis

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