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

2021년 5월 31일 업데이트: 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.

연구 개요

상세 설명

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

연구 유형

중재적

등록 (실제)

1002

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Cordoba, 스페인, 14001
        • Reina Sofia University Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

20년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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)
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)
실험적: Mediterranean Diet
Dietary Intervention with a Mediterranean Diet: 35-38% fat (22% monounsaturated fatty acids; 6% polyunsaturated fatty acids; <10% saturated fatty acids).
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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.
기간: 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

2차 결과 측정

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

기타 결과 측정

결과 측정
측정값 설명
기간
Endothelial function (Flow mediated dilation)
기간: 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
기간: Up to seven years
Influence of genetic data in the development clinical outcomes
Up to seven years
postprandial lipaemia
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2009년 11월 1일

기본 완료 (실제)

2018년 7월 1일

연구 완료 (실제)

2021년 5월 1일

연구 등록 날짜

최초 제출

2009년 6월 18일

QC 기준을 충족하는 최초 제출

2009년 6월 18일

처음 게시됨 (추정)

2009년 6월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 5월 31일

마지막으로 확인됨

2021년 5월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Low Fat Diet에 대한 임상 시험

구독하다