CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention (CORDIOPREV)

• Incidence of intermittent claudication. [ Time Frame: Five years ] [ Designated as safety issue: No ]
• Concentration of LDL cholesterol. [ Time Frame: Five years ] [ Designated as safety issue: No ]
• Atherogenic ratio Total cholesterol/HDL and LDL/HDL. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
• Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose). [ Time Frame: Five Years ] [ Designated as safety issue: No ]
• Blood pressure. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
• Response to ergometry tests. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
• Incidence of malignancy. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
• Progression of Cognitive Decline. [ Time Frame: Five Years ] [ Designated as safety issue: No ]

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 874 patients with coronary disease that will undergo one of two diets in a randomized design (two groups of 437 patients each) for 5 years. The two diets will be: a)Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT) and b) Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).

Primary Objective: To compare the effects of the two dietary patterns on the 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 after 5 years.

Secondary objectives:

• To compare the incidence of intermittent claudication.
• To compare the concentration of LDL cholesterol.
• To compare the atherogenic ratio Total cholesterol/HDL and LDL/HDL.
• To compare the metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose).
• To compare blood pressure.
• To compare the response to ergometry tests.
• To compare the incidence of Cancer.
• To compare the cognitive decline.

• Myocardial Infarction
• Unstable Angina
• Malignancy
• Cognitive Decline

• Behavioral: Diet
  Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).
  Other Name: Dieta Mediterranea
• Behavioral: Diet
  Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT)
  Other Name: Dieta Baja en grasas

• Active Comparator: Low Fat
  Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT)
  Intervention: Behavioral: Diet
• Experimental: Mediterranean Diet
  Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).
  Intervention: Behavioral: Diet

Inclusion Criteria:

• Informed Consent

• Clinical: Unstable coronary disease

  • Acute Myocardial Infarction
  • Unstable Angina
  • Chronic Coronary Disease at high risk for event

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
  • COPD
  • Diseases of the digestive tract Endocrine disorders
• Patients participating in other Clinical trials (in the enrollment moment or 30 days prior).