Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease
20 Years
75 Years
Both
Myocardial Infarction, Unstable Angina, Malignancy, Cognitive Decline
Trial Information
Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients 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.
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
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.
Outcome Time Frame:
Five Years
Safety Issue:
No
Principal Investigator
Francisco Perez-Jimenez, MD,PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Reina Sofia University Hospital
Authority:
Spain: Ethics Committee
Study ID:
CORDIOPREV
NCT ID:
NCT00924937
Start Date:
November 2009
Completion Date:
November 2018
Related Keywords:
- Myocardial Infarction
- Unstable Angina
- Malignancy
- Cognitive Decline
- Cardiovascular events
- Blood pressure
- Incidence of Cancer
- Cognitive decline
- Mediterranean Diet
- Secondary Prevention
- Low fat diet
- Angina, Unstable
- Neoplasms
- Infarction
- Myocardial Infarction
- Cognition Disorders
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