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

31. maj 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1002

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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)
Adfærdsmæssigt: Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Eksperimentel: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Adfærdsmæssigt: Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis.
Tidsramme: Seven Years
Data from clinical and/or diagnostic tests will be analyzed
Seven Years
Concentration of LDL cholesterol.
Tidsramme: Seven Years
Concentration of LDL cholesterol in blood samples
Seven Years
Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL.
Tidsramme: 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).
Tidsramme: Seven Years
Study of the metabolism of carbohydrates during the trial
Seven Years
Blood pressure.
Tidsramme: Seven Years
Study of blood pressure in response to the study
Seven Years
Incidence of malignancy.
Tidsramme: Seven Years
Appearance of malignancy
Seven Years
Progression of Cognitive Decline.
Tidsramme: Seven Years
Cognitive decline will be evaluated by validated questionnaires
Seven Years
Extended composite of cardiovascular disease progression
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to Seven Years
Incidence of type 2 Diabetes Mellitus during the study
Up to Seven Years
Anthropometric changes. Metabolic disease
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to Seven Years
Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied
Up to Seven Years
AGEs
Tidsramme: Up to Seven Years
Metabolism of advanced glycation end products.
Up to Seven Years
Mineral metabolism
Tidsramme: Up to Seven Years
Impact of mineral metabolism on atherosclerosis
Up to Seven Years
Echographic markers of cardiac function and clinical outcomes
Tidsramme: Up to Seven Years
Cardiac function studies by Echocardiography at baseline and during the study
Up to Seven Years
Microparticles
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endothelial function (Flow mediated dilation)
Tidsramme: 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
Tidsramme: Up to seven years
Influence of genetic data in the development clinical outcomes
Up to seven years
postprandial lipaemia
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital Universitario Reina Sofia de Cordoba

Efterforskere

  • Ledende efterforsker: Francisco Perez-Jimenez, MD,PhD, Reina Sofia University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2009

Primær færdiggørelse (Faktiske)

1. juli 2018

Studieafslutning (Faktiske)

1. maj 2021

Datoer for studieregistrering

Først indsendt

18. juni 2009

Først indsendt, der opfyldte QC-kriterier

18. juni 2009

Først opslået (Skøn)

19. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CORDIOPREV

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Myokardieinfarkt

Kliniske forsøg med Low Fat Diet

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Jamaica

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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