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
  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
Behavioral: Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 874
Study Start Date: November 2009
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Fat
Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT)
Behavioral: Diet
Low fat diet: 28% fat (12% MUFA; 8%PUFA; 8% SAT)
Other Name: Dieta Baja en grasas
Experimental: Mediterranean Diet
Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).
Behavioral: Diet
Mediterranean Diet: 34% fat (22% MUFA; 6% PUFA; 7% SAT).
Other Name: Dieta Mediterranea

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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:
No publications provided

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: August 26, 2014
Health Authority: Spain: Ethics Committee

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:
Infarction
Myocardial Infarction
Cognition Disorders
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014