The AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial): A randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: Study protocol

Catherine Itsiopoulos, Teagan Kucianski, Hannah L. Mayr, William J. van Gaal, Miguel Angel Martinez-Gonzalez, Hassan Vally, Michael Kingsley, Antigone Kouris-Blazos, Jessica Radcliffe, Leonie Segal, Laima Brazionis, Agus Salim, Audrey C. Tierney, Kerin O'Dea, Andrew Wilson, Colleen J. Thomas

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Abstract

The Mediterranean diet was first characterized as a heart-protective diet in the 1960s. The significant cardioprotective effects of the Mediterranean diet in comparison to the standard-care low-fat diet have been established in the primary prevention of cardiovascular disease (CVD); however, there is insufficient evidence in secondary prevention research to influence the current standard of care. Opportunity exists to assess the Mediterranean diet as a therapeutic target for secondary CVD prevention within Australia's ethnoculturally diverse communities. The AUSMED Heart Trial is a multisite randomized controlled trial that will evaluate the efficacy of the Mediterranean diet for secondary prevention of CVD in the Australian health care setting. This trial aims to evaluate the effect of a 6-month Mediterranean diet intervention (delivered by dietitians) versus a “standard-care” low-fat diet in reducing the composite incidence of cardiovascular events at 12 months and at trial end in participants with documented evidence of a previous acute myocardial infarction at trial entry. The quality of the diet at baseline and follow-up will be assessed using comprehensive dietary questionnaires and diaries as well as relevant dietary biomarkers (such as urinary polyphenols and erythrocyte fatty acids). Cardiovascular risk markers, including novel measures of immune and inflammatory status, endothelial function, vascular compliance, platelet activity, and body composition, will be collected to explore possible mechanisms for treatment effect. Cost-effectiveness will also be estimated to support policy translation. We plan to recruit 1,032 participants (516 per arm) from cardiology clinics in major Australian hospitals in Melbourne, Adelaide, and Brisbane.

Original languageEnglish
Pages (from-to)4-11
Number of pages8
JournalAmerican Heart Journal
Volume203
Early online date24 May 2018
DOIs
Publication statusPublished - 1 Sep 2018
Externally publishedYes

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Mediterranean Diet
Secondary Prevention
Coronary Disease
Randomized Controlled Trials
Population
Fat-Restricted Diet
Cardiovascular Diseases
Diet
Nutritionists
Polyphenols
Primary Prevention
Standard of Care
Body Composition
Cardiology
Compliance
Cost-Benefit Analysis
Blood Vessels
Fatty Acids
Blood Platelets
Erythrocytes

Cite this

Itsiopoulos, Catherine ; Kucianski, Teagan ; Mayr, Hannah L. ; van Gaal, William J. ; Martinez-Gonzalez, Miguel Angel ; Vally, Hassan ; Kingsley, Michael ; Kouris-Blazos, Antigone ; Radcliffe, Jessica ; Segal, Leonie ; Brazionis, Laima ; Salim, Agus ; Tierney, Audrey C. ; O'Dea, Kerin ; Wilson, Andrew ; Thomas, Colleen J. / The AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial) : A randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: Study protocol. In: American Heart Journal. 2018 ; Vol. 203. pp. 4-11.
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abstract = "The Mediterranean diet was first characterized as a heart-protective diet in the 1960s. The significant cardioprotective effects of the Mediterranean diet in comparison to the standard-care low-fat diet have been established in the primary prevention of cardiovascular disease (CVD); however, there is insufficient evidence in secondary prevention research to influence the current standard of care. Opportunity exists to assess the Mediterranean diet as a therapeutic target for secondary CVD prevention within Australia's ethnoculturally diverse communities. The AUSMED Heart Trial is a multisite randomized controlled trial that will evaluate the efficacy of the Mediterranean diet for secondary prevention of CVD in the Australian health care setting. This trial aims to evaluate the effect of a 6-month Mediterranean diet intervention (delivered by dietitians) versus a “standard-care” low-fat diet in reducing the composite incidence of cardiovascular events at 12 months and at trial end in participants with documented evidence of a previous acute myocardial infarction at trial entry. The quality of the diet at baseline and follow-up will be assessed using comprehensive dietary questionnaires and diaries as well as relevant dietary biomarkers (such as urinary polyphenols and erythrocyte fatty acids). Cardiovascular risk markers, including novel measures of immune and inflammatory status, endothelial function, vascular compliance, platelet activity, and body composition, will be collected to explore possible mechanisms for treatment effect. Cost-effectiveness will also be estimated to support policy translation. We plan to recruit 1,032 participants (516 per arm) from cardiology clinics in major Australian hospitals in Melbourne, Adelaide, and Brisbane.",
author = "Catherine Itsiopoulos and Teagan Kucianski and Mayr, {Hannah L.} and {van Gaal}, {William J.} and Martinez-Gonzalez, {Miguel Angel} and Hassan Vally and Michael Kingsley and Antigone Kouris-Blazos and Jessica Radcliffe and Leonie Segal and Laima Brazionis and Agus Salim and Tierney, {Audrey C.} and Kerin O'Dea and Andrew Wilson and Thomas, {Colleen J.}",
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Itsiopoulos, C, Kucianski, T, Mayr, HL, van Gaal, WJ, Martinez-Gonzalez, MA, Vally, H, Kingsley, M, Kouris-Blazos, A, Radcliffe, J, Segal, L, Brazionis, L, Salim, A, Tierney, AC, O'Dea, K, Wilson, A & Thomas, CJ 2018, 'The AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial): A randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: Study protocol' American Heart Journal, vol. 203, pp. 4-11. https://doi.org/10.1016/j.ahj.2018.05.010

The AUStralian MEDiterranean Diet Heart Trial (AUSMED Heart Trial) : A randomized clinical trial in secondary prevention of coronary heart disease in a multiethnic Australian population: Study protocol. / Itsiopoulos, Catherine; Kucianski, Teagan; Mayr, Hannah L.; van Gaal, William J.; Martinez-Gonzalez, Miguel Angel; Vally, Hassan; Kingsley, Michael; Kouris-Blazos, Antigone; Radcliffe, Jessica; Segal, Leonie; Brazionis, Laima; Salim, Agus; Tierney, Audrey C.; O'Dea, Kerin; Wilson, Andrew; Thomas, Colleen J.

In: American Heart Journal, Vol. 203, 01.09.2018, p. 4-11.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Brazionis, Laima

AU - Salim, Agus

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