Reina Sofia University Hospital
Córdoba, 14001, Spain
NCT Number: NCT00924937
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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Notify Me20 year–75 year
All sexes
Interventional
Not applicable
Córdoba, 14001, Spain
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
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.
Time frame: Seven Years
Data from clinical and/or diagnostic tests will be analyzed
Time frame: Seven Years
Concentration of LDL cholesterol in blood samples
Time frame: Seven Years
Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
Time frame: Seven Years
Study of the metabolism of carbohydrates during the trial
Time frame: Seven Years
Study of blood pressure in response to the study
Time frame: Seven Years
Appearance of malignancy
Time frame: Seven Years
Cognitive decline will be evaluated by validated questionnaires
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.
Time frame: Seven Years
Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
Time frame: Up to Seven Years
Incidence of type 2 Diabetes Mellitus during the study
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
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.
Time frame: Up to Seven Years
Study of relationship between existing or new Arrhythmias on clinical events
Time frame: Up to Seven Years
Individual apparition of hard cardiovascular events:
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.
Time frame: Up to Seven Years
Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
Time frame: Up to Seven Years
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
Time frame: Up to Seven Years
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
Time frame: Up to Seven Years
Metabolism of advanced glycation end products.
Time frame: Up to Seven Years
Impact of mineral metabolism on atherosclerosis
Time frame: Up to Seven Years
Cardiac function studies by Echocardiography at baseline and during the study
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
Time frame: Up to Seven Years
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
Time frame: Up to seven years
Influence of genetic data in the development clinical outcomes
Time frame: Up to seven years
Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables
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
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
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
Hospital Universitario Reina Sofia de Cordoba
Other Gov
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
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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