Elsevier

American Heart Journal

Volume 177, July 2016, Pages 42-50
American Heart Journal

Trial Design
CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics: A clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low-fat diet on cardiovascular disease in coronary patients

https://doi.org/10.1016/j.ahj.2016.04.011Get rights and content

Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years in subjects with documented CHD at baseline. For this purpose, we enrolled 1,002 coronary patients from Spain. Baseline assessment (2009-2012) included detailed interviews and measurements to assess dietary, social, and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high body mass index (37.2% overweight and 56.3% obesity) and with a median of low-density lipoprotein cholesterol of 88.5 mg/dL (70.6% of the patients having <100 mg/dL and 20.3% patients <70 mg/dL). A total of 9.6% of the participants were active smokers, and 64.4% were former smokers. Metabolic syndrome was present in 58% of this population. To sum up, we describe here the rationale, methods, and baseline characteristics of the CORDIOPREV study, which will test for the first time the efficacy of a Mediterranean diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study.

Section snippets

Objectives

The primary outcome of the CORDIOPREV study is to compare the appearance of a composite of cardiovascular events after an average follow-up of 7 years in secondary prevention with 2 dietary models: a Mediterranean diet (rich in olive oil) and a low-fat diet. The composite outcome includes the following cardiovascular events: myocardial infarction, revascularization, ischemic stroke, documented peripheral artery disease, and cardiovascular death.

Prespecified secondary outcomes include clinical,

Overall design

The CORDIOPREV study (Clinicaltrials.gov number NCT00924937) is a randomized, single-blind, controlled dietary intervention trial in CHD patients with high cardiovascular risk, with an intention-to-treat analysis basis.

The study is being conducted at the Instituto Maimonides de Investigacion Biomedica de Cordoba, a scientific institute which carries out research into biomedical areas for the Reina Sofia University Hospital, and the University of Cordoba, Spain. The lipids and atherosclerosis

Results of baseline measurements

Up to February 2012, a total of 1,002 participants were included in the CORDIOPREV study. Table IV shows baseline characteristics. The mean age was 59.5 years. The subjects were predominantly male (83.5%), former smokers (64.6%), and consumers of alcohol (82.6%), mostly in moderation (<14 g/d, mainly red wine). Adherence rates to the Mediterranean diet and the low-fat scores were 8.78 and 3.81 for the whole sample (regardless of the randomization group to which they were assigned), on scores

Discussion and conclusions

The evidence for the influence of the Mediterranean diet on the clinical course of CHD is sparse. Despite the well-established healthy effects of this dietary pattern on multiple cardiovascular risk factors, either traditional ones such as lipids or hypertension, or new emerging ones (endothelial function, oxidative stress, inflammation, obesity, metabolic syndrome, or type 2 diabetes mellitus),14, 15, 24, 42, 43, 44 there is a paucity of studies evaluating its effectiveness in reducing the

Funding and Acknowledgements

We would like to thank the Escuela Andaluza de Salud Pública and especially Dr Antonio Daponte for performing the randomization process. We also want to thank Dr Miguel Angel Martinez González for his valuable help in the statistical approach. The CORDIOPREV study is supported by the Fundacion Patrimonio Comunal Olivarero. The main sponsor agreed to participate in the study because, when it started, there were no full-length studies evaluating the effect of an olive oil–based Mediterranean diet

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    RCT# NCT0092493741

    The CORDIOPREV study is supported by the Fundacion Patrimonio Comunal Olivarero. Also received additional funding from CITOLIVA, CEAS, Junta de Andalucia (Consejeria de Salud, Consejeria de Agricultura y Pesca, Consejeria de Innovacion, Ciencia y Empresa), Diputaciones de Jaen y Cordoba, Centro de Excelencia en Investigacion sobre Aceite de Oliva y Salud and Ministerio de Medio Ambiente, Medio Rural y Marino, and the Spanish Government. The study was also cofinanced by the Fondo Europeo de Desarrollo Regional. Also partly supported by research grants from the Ministerio de Ciencia e Innovacion (AGL2009-122270 to J. L.-M., FIS PI10/01041 to P. P.-M., FIS PI13/00023 to J. D.-L.); Ministerio de Economia y Competitividad (AGL2012/39615 to J. L.-M.); Consejeria de Salud, Junta de Andalucia (PI0193/09 to J. L.-M., PI-0252/09 to J. D.-L., PI-0058/10 to P. P.-M., PI-0206-2013 to A. G.-R.); and Proyecto de Excelencia, Consejería de Economía, Innovación, Ciencia y Empleo (CVI-7450 to J. L.-M.).

    g

    These 2 authors contributed equally to this article as first authors.

    h

    These two authors contributed equally as corresponding authors and main researchers of this article.

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