Status:
COMPLETED
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
Lead Sponsor:
Hospital Universitario Reina Sofia de Cordoba
Conditions:
Myocardial Infarction
Unstable Angina
Eligibility:
All Genders
20-75 years
Phase:
NA
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 c...
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) ...
Eligibility Criteria
Inclusion
- Informed Consent
- Clinical: Unstable coronary disease with documented vessel/myocardial damage
- Acute Myocardial Infarction
- Revascularization
Exclusion
- 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).
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
1002 Patients enrolled
Trial Details
Trial ID
NCT00924937
Start Date
November 1 2009
End Date
May 1 2021
Last Update
June 3 2021
Active Locations (1)
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1
Reina Sofia University Hospital
Córdoba, Spain, 14001