CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention

Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00924937
• Other study ID #: CORDIOPREV
• Status: Completed
• Phase: N/A
• Start date: November 2009
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: Hospital Universitario Reina Sofia de Cordoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: May 2021
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Angina, Unstable
• Cognitive Decline
• Cognitive Dysfunction
• Diabetes Mellitus
• Infarction
• Malignancy
• Metabolic Syndrome
• Myocardial Infarction
• Unstable Angina

Intervention

Behavioral:
• Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
• Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)

Locations

Country	Name	City	State
Spain	Reina Sofia University Hospital	Cordoba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Reina Sofia de Cordoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endothelial function (Flow mediated dilation)	Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed	Up to Seven Years
Other	genetics, genomics and epigenetics	Influence of genetic data in the development clinical outcomes	Up to seven years
Other	postprandial lipaemia	Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables	Up to seven years
Other	Study of other Clinical events	Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease	Up to seven years
Other	Subgroup Studies	Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function	Up to seven years
Other	Further Studies	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	Up to Seven Years
Primary	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.	Seven Years
Secondary	Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.	Data from clinical and/or diagnostic tests will be analyzed	Seven Years
Secondary	Concentration of LDL cholesterol.	Concentration of LDL cholesterol in blood samples	Seven Years
Secondary	Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.	Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study	Seven Years
Secondary	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	Seven Years
Secondary	Blood pressure.	Study of blood pressure in response to the study	Seven Years
Secondary	Incidence of malignancy.	Appearance of malignancy	Seven Years
Secondary	Progression of Cognitive Decline.	Cognitive decline will be evaluated by validated questionnaires	Seven Years
Secondary	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.	Seven Years
Secondary	Extended composite of heart events	Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest	Seven Years
Secondary	Incidence of type 2 Diabetes Mellitus	Incidence of type 2 Diabetes Mellitus during the study	Up to Seven Years
Secondary	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	Up to Seven Years
Secondary	Gut Microbiota	Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.	Up to Seven Years
Secondary	Arrhythmias	Study of relationship between existing or new Arrhythmias on clinical events	Up to Seven Years
Secondary	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	Up to Seven Years
Secondary	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.	Up to Seven Years
Secondary	Specific metabolomics	Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc	Up to Seven Years
Secondary	Gene Expression	Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc	Up to Seven Years
Secondary	Inflammation and oxidative stress	Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied	Up to Seven Years
Secondary	AGEs	Metabolism of advanced glycation end products.	Up to Seven Years
Secondary	Mineral metabolism	Impact of mineral metabolism on atherosclerosis	Up to Seven Years
Secondary	Echographic markers of cardiac function and clinical outcomes	Cardiac function studies by Echocardiography at baseline and during the study	Up to Seven Years
Secondary	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	Up to Seven Years
Secondary	Subgroup analysis	27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function	Up to Seven Years

External Links

•   Webpage of the study