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

31. mai 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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

Studietype

Intervensjonell

Registrering (Faktiske)

1002

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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)
Atferdsmessig: Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
Eksperimentell: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Atferdsmessig: Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital Universitario Reina Sofia de Cordoba

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2009

Primær fullføring (Faktiske)

1. juli 2018

Studiet fullført (Faktiske)

1. mai 2021

Datoer for studieregistrering

Først innsendt

18. juni 2009

Først innsendt som oppfylte QC-kriteriene

18. juni 2009

Først lagt ut (Anslag)

19. juni 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mai 2021

Sist bekreftet

1. mai 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CORDIOPREV

Plan for individuelle deltakerdata (IPD)

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NEI

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