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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00924937
Other study ID # CORDIOPREV
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date May 2021

Study information

Verified date May 2021
Source Hospital Universitario Reina Sofia de Cordoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 1002
Est. completion date May 2021
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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).

Study Design


Intervention

Behavioral:
Mediterranean Diet
Mediterranean Diet:35-38% fat (22% MUFA; 6% PUFA; <10% SAT).
Low Fat Diet
Low fat diet: <30% fat (12% MUFA; 6-8%PUFA; <10% SAT)

Locations

Country Name City State
Spain Reina Sofia University Hospital Cordoba

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario Reina Sofia de Cordoba

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Endothelial function (Flow mediated dilation) 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
Other genetics, genomics and epigenetics Influence of genetic data in the development clinical outcomes Up to seven years
Other postprandial lipaemia Postprandial lipemia study based on oral fat tolerance test depending on clinical and genetic variables Up to seven years
Other Study of other Clinical events 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
Other Subgroup Studies Differential impact on certain subgroups: Sex, age, anthropometry, genetics, genomics, metabolism of immediate principles, cardiovascular risk factors, cancer, vascular function Up to seven years
Other Further Studies 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
Primary 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. 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
Secondary Evolution of arteriosclerosis: Evaluation of arteriosclerosis at different vascular beds. Silent arteriosclerosis. Data from clinical and/or diagnostic tests will be analyzed Seven Years
Secondary Concentration of LDL cholesterol. Concentration of LDL cholesterol in blood samples Seven Years
Secondary Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL. Comparison of Atherogenic ratio, and Total cholesterol/HDL and LDL/HDL during the study Seven Years
Secondary Metabolic control of carbohydrates (assessed by glycemic and insulin responses to intravenous tolerance test to glucose, basal glycemia and hba1c). Study of the metabolism of carbohydrates during the trial Seven Years
Secondary Blood pressure. Study of blood pressure in response to the study Seven Years
Secondary Incidence of malignancy. Appearance of malignancy Seven Years
Secondary Progression of Cognitive Decline. Cognitive decline will be evaluated by validated questionnaires Seven Years
Secondary Extended composite of cardiovascular disease progression 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
Secondary Extended composite of heart events Incidence of cardiac death , myocardial infarction , unstable angina , revascularization, heart failure, heart transplantation, cardiac arrest Seven Years
Secondary Incidence of type 2 Diabetes Mellitus Incidence of type 2 Diabetes Mellitus during the study Up to Seven Years
Secondary Anthropometric changes. Metabolic disease 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
Secondary Gut Microbiota 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
Secondary Arrhythmias Study of relationship between existing or new Arrhythmias on clinical events Up to Seven Years
Secondary Individual evaluation of all components of the primary outcome. Individual apparition of hard cardiovascular events:
myocardial infarction
revascularization
ischemic stroke
documented peripheral artery disease
cardiovascular death
Up to Seven Years
Secondary Global Metabolomics 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
Secondary Specific metabolomics Specific metabolomics in plasma fractions, specific bioparticles such as lipoproteins or specific cells, lipidomics, proteomics, targeted metabolomics, etc Up to Seven Years
Secondary Gene Expression Changes in Gene Expression using transcriptomic techniques such as gene expression microarrays, quantitative PCR, GeneChip, etc Up to Seven Years
Secondary Inflammation and oxidative stress Different physiological processes or metabolic pathways related to inflammation and oxidative stress will be studied Up to Seven Years
Secondary AGEs Metabolism of advanced glycation end products. Up to Seven Years
Secondary Mineral metabolism Impact of mineral metabolism on atherosclerosis Up to Seven Years
Secondary Echographic markers of cardiac function and clinical outcomes Cardiac function studies by Echocardiography at baseline and during the study Up to Seven Years
Secondary Microparticles 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
Secondary Subgroup analysis 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
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