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

31 mai 2021 mis à jour par: Francisco Perez Jimenez, Hospital Universitario Reina Sofia de Cordoba

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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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 (MUFA); 6-8% polyunsaturated fatty acid (PUFA) ; <10% SAT) and b) Mediterranean Diet: >35% fat (22% MUFA; 6% PUFA ; <10% SAT).

Primary Objective:

Combined apparition of hard cardiovascular events (myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease or cardiovascular death).

Secondary Objectives:

Those related in the Outcome Measures section of this webpage

Type d'étude

Interventionnel

Inscription (Réel)

1002

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Espagne
      • Cordoba, Espagne, 14001
        • Reina Sofia University Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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)
Comportemental: Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Expérimental: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Comportemental: Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: Seven Years
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.
Seven Years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Délai: Seven Years
Data from clinical and/or diagnostic tests will be analyzed
Seven Years
Concentration of LDL cholesterol.
Délai: Seven Years
Concentration of LDL cholesterol in blood samples
Seven Years
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
Délai: Seven Years
Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study
Seven Years
Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c).
Délai: Seven Years
Study of the metabolism of carbohydrates during the trial
Seven Years
Blood pressure.
Délai: Seven Years
Study of blood pressure in response to the study
Seven Years
Incidence of malignancy.
Délai: Seven Years
Appearance of malignancy
Seven Years
Progression of Cognitive Decline.
Délai: Seven Years
Cognitive decline will be evaluated by validated questionnaires
Seven Years
Extended composite of cardiovascular disease progression
Délai: Seven Years
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.
Seven Years
Extended composite of heart events
Délai: Seven Years
Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest
Seven Years
Incidence of type 2 Diabetes Mellitus
Délai: Up to Seven Years
Incidence of type 2 Diabetes Mellitus during the study
Up to Seven Years
Anthropometric changes. Metabolic disease
Délai: Up to Seven Years
Clinical features of metabolic disease: Metabolic Syndrome, Metabolic Phenotypes of Obesity or other classifications based on anthropometric features will be assessed during the study
Up to Seven Years
Gut Microbiota
Délai: Up to Seven Years
Changes in the percentage of different families of Microbiota will be analyzed during the study, and their impact on clinical events.
Up to Seven Years
Arrhythmias
Délai: Up to Seven Years
Study of relationship between existing or new Arrhythmias on clinical events
Up to Seven Years
Individual evaluation of all components of the primary outcome.
Délai: Up to Seven Years

Individual apparition of hard cardiovascular events:

  • myocardial infarction
  • revascularization
  • ischemic stroke
  • documented peripheral artery disease
  • cardiovascular death
Up to Seven Years
Global Metabolomics
Délai: Up to Seven Years
Global metabolomics in plasma, as well as techniques targeting specific sets of metabolites such as lipid-based lipid species, protein by proteomics, etc.
Up to Seven Years
Specific metabolomics
Délai: Up to Seven Years
Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc
Up to Seven Years
Gene Expression
Délai: Up to Seven Years
Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc
Up to Seven Years
Inflammation and oxidative stress
Délai: Up to Seven Years
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
Up to Seven Years
AGEs
Délai: Up to Seven Years
Metabolism of advanced glycation end products.
Up to Seven Years
Mineral metabolism
Délai: Up to Seven Years
Impact of mineral metabolism on atherosclerosis
Up to Seven Years
Echographic markers of cardiac function and clinical outcomes
Délai: Up to Seven Years
Cardiac function studies by Echocardiography at baseline and during the study
Up to Seven Years
Microparticles
Délai: Up to Seven Years
Study of endothelial microparticles (vesicles formed from endothelial cells membrane after injury). The quantification of the EPCs and EMPs will be performed by flow cytometry
Up to Seven Years
Subgroup analysis
Délai: Up to Seven Years
27. Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Up to Seven Years

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Endothelial function (Flow mediated dilation)
Délai: Up to Seven Years
Endothelium response to ischemia in the brachial artery. Area under the curve, flow peak and time to maximum flow will be performed
Up to Seven Years
genetics, genomics and epigenetics
Délai: Up to seven years
Influence of genetic data in the development clinical outcomes
Up to seven years
postprandial lipaemia
Délai: Up to seven years
Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables
Up to seven years
Study of other Clinical events
Délai: Up to seven years
Clinical events not qualifying as primary endpoint nor in the secondary objectives 1 and 2, especially those associated with cardiovascular disease
Up to seven years
Subgroup Studies
Délai: Up to seven years
Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function
Up to seven years
Further Studies
Délai: Up to Seven Years
Additional secondary objectives will be carried out in light of current and/or future knowledge of ischemic heart disease risk factors, prognostic factors and pathophysiological pathways, and will include, but not be limited to, endothelial function, inflammation, cell biology, molecular biology, proteomics, genetics and epigenetics
Up to Seven Years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospital Universitario Reina Sofia de Cordoba

Les enquêteurs

  • Chercheur principal: Francisco Perez-Jimenez, MD,PhD, Reina Sofia University Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2009

Achèvement primaire (Réel)

1 juillet 2018

Achèvement de l'étude (Réel)

1 mai 2021

Dates d'inscription aux études

Première soumission

18 juin 2009

Première soumission répondant aux critères de contrôle qualité

18 juin 2009

Première publication (Estimation)

19 juin 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 mai 2021

Dernière vérification

1 mai 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CORDIOPREV

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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