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: March 2, 2016
Last verified: March 2016

June 18, 2009
March 2, 2016
November 2009
February 2019   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT00924937 on ClinicalTrials.gov Archive Site
  • Incidence of intermittent claudication. [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
  • Concentration of LDL cholesterol. [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
  • Atherogenic ratio Total cholesterol/HDL and LDL/HDL. [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
  • Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose). [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
  • Blood pressure. [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
  • Incidence of malignancy. [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
  • Progression of Cognitive Decline. [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
  • Extended composite of cardiovascular disease progression [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
    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.
  • Extended composite of heart events [ Time Frame: Seven Years ] [ Designated as safety issue: No ]
    Cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
  • Incidence of type 2 Diabetes Mellitus [ Time Frame: Up to Seven Years ] [ Designated as safety issue: No ]
  • Incidence of Metabolic Syndrome [ Time Frame: Up to Seven Years ] [ Designated as safety issue: No ]
  • Composition of the different families of Gut Microbiota [ Time Frame: Up to Seven Years ] [ Designated as safety issue: No ]
    Changes in the percentage of different families of Microbiota will be analyzed during the study
  • 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 ]
  • Endothelial function (Flow mediated dilation) [ Time Frame: Up to Seven Years ] [ Designated as safety issue: No ]
    Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed
  • genetics [ Time Frame: Up to seven years ] [ Designated as safety issue: No ]
    Influence of genotype in the development of type 2 dm, at 1, 2, 4 and 7 years
  • postprandial lipaemia [ Time Frame: Up to seven years ] [ Designated as safety issue: No ]
    Influence of metabolic phenotypes and diet on postprandial lipemia
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 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; 6-8% polyunsaturated fatty acid ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acid ; <10% SAT).

Primary Objective:

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 Objectives:

Those related in the Outcome Measures section of this webpage

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Myocardial Infarction
  • Unstable Angina
  • Malignancy
  • Cognitive Decline
  • Diabetes Mellitus
  • Metabolic Syndrome
  • Behavioral: Mediterranean Diet
    Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
    Other Name: Dieta Mediterranea
  • Behavioral: Low Fat Diet
    Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
    Other Name: Dieta Baja en grasas
  • Active Comparator: Low Fat Diet
    Dietary Intervention with a Low fat diet: <30% fat (12% monounsaturated fatty acids; 6-8%polyunsaturated fatty acids; <10% saturated fatty acids)
    Intervention: Behavioral: Low Fat Diet
  • Experimental: Mediterranean Diet
    Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
    Intervention: Behavioral: Mediterranean Diet

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1002
September 2019
February 2019   (final data collection date for primary outcome measure)

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
    • 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).
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00924937
CORDIOPREV
Yes
No
Not Provided
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
March 2016

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