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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Francisco Perez Jimenez, Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier:
NCT00924937
First received: June 18, 2009
Last updated: August 26, 2014
Last verified: August 2014

June 18, 2009
August 26, 2014
November 2009
November 2016   (final data collection date for primary 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. [ Time Frame: Five Years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00924937 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CORonary Diet Intervention With Olive Oil and Cardiovascular PREVention
Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
874
November 2018
November 2016   (final data collection date for primary outcome measure)

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).
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00924937
CORDIOPREV
Yes
Francisco Perez Jimenez, Hospital Universitario Reina Sofia
Hospital Universitario Reina Sofia
Not Provided
Principal Investigator: Francisco Perez-Jimenez, MD,PhD Reina Sofia University Hospital
Hospital Universitario Reina Sofia
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP