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
  Purpose
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.

Condition Intervention
Myocardial Infarction
Unstable Angina
Malignancy
Cognitive Decline
Diabetes Mellitus
Metabolic Syndrome
Behavioral: Mediterranean Diet
Behavioral: Low Fat Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Clinical Trial on the Effects of Mediterranean Diet (Rich on Olive Oil) in the Reduction of Coronary Events of Patients With Coronary Disease

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Reina Sofia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Enrollment: 1002
Study Start Date: November 2009
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Behavioral: Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Other Name: Dieta Baja en grasas
Experimental: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Behavioral: Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
Other Name: Dieta Mediterranea

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) 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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924937

Locations
Spain
Reina Sofia University Hospital
Cordoba, Spain, 14001
Sponsors and Collaborators
Hospital Universitario Reina Sofia
Investigators
Principal Investigator: Francisco Perez-Jimenez, MD,PhD Reina Sofia University Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francisco Perez Jimenez, Chief of Internal Medicine Unit, Hospital Universitario Reina Sofia
ClinicalTrials.gov Identifier: NCT00924937     History of Changes
Other Study ID Numbers: CORDIOPREV 
Study First Received: June 18, 2009
Last Updated: March 2, 2016
Health Authority: Spain: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hospital Universitario Reina Sofia:
Cardiovascular events
Blood pressure
Incidence of Cancer
Cognitive decline
Mediterranean Diet
Secondary Prevention
Low fat diet

Additional relevant MeSH terms:
Diabetes Mellitus
Infarction
Myocardial Infarction
Metabolic Syndrome X
Cognition Disorders
Angina, Unstable
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Neurocognitive Disorders
Mental Disorders
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2016