Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Enrollment
- 1002
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Francisco Perez Jimenez
Chief of Internal Medicine Unit
Hospital Universitario Reina Sofia de Cordoba
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
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
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 Outcomes
- Inflammation and oxidative stress(Up to Seven Years)
- Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.(Seven Years)
- Concentration of LDL cholesterol.(Seven Years)
- Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.(Seven Years)
- Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).(Seven Years)
- Blood pressure.(Seven Years)
- Incidence of malignancy.(Seven Years)
- Progression of Cognitive Decline.(Seven Years)
- Extended composite of cardiovascular disease progression(Seven Years)
- Extended composite of heart events(Seven Years)
- Incidence of type 2 Diabetes Mellitus(Up to Seven Years)
- Anthropometric changes. Metabolic disease(Up to Seven Years)
- Gut Microbiota(Up to Seven Years)
- Arrhythmias(Up to Seven Years)
- Individual evaluation of all components of the primary outcome.(Up to Seven Years)
- Global Metabolomics(Up to Seven Years)
- Gene Expression(Up to Seven Years)
- Specific metabolomics(Up to Seven Years)
- AGEs(Up to Seven Years)
- Mineral metabolism(Up to Seven Years)
- Echographic markers of cardiac function and clinical outcomes(Up to Seven Years)
- Microparticles(Up to Seven Years)
- Subgroup analysis(Up to Seven Years)