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Open Access Study protocol

Hypotheses, rationale, design, and methods for prognostic evaluation in type 2 diabetic patients with angiographically normal coronary arteries. The MASS IV-DM Trial

Whady Hueb1*, Neuza Lopes1, Paulo R Soares1, Bernard J Gersh2, Eduardo Gomes Lima1, Ricardo D´Oliveira Vieira1, Cibele Larrosa Garzillo1, Rosa Rhami Garcia1, Alexandre Costa Pereira1, Celia Maria Strunz1, Claudio Meneguetti1, Jeane Tsutsui1, Jose Parga1, Pedro Lemos1, Alexandre Hueb1, Augusto Ushida1, Raul Maranhão1, Dalton A Chamone1 and Jose AF Ramires1

Author Affiliations

1 From the Heart Institute of the University of São Paulo, São Paulo, Brazil

2 Mayo Clinic, Rochester, Minnesota, USA

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BMC Cardiovascular Disorders 2010, 10:47  doi:10.1186/1471-2261-10-47

Published: 29 September 2010

Abstract

Background

The MASS IV-DM Trial is a large project from a single institution, the Heart Institute (InCor), University of São Paulo Medical School, Brazil to study ventricular function and coronary arteries in patients with type 2 diabetes mellitus.

Methods/Design

The study will enroll 600 patients with type 2 diabetes who have angiographically normal ventricular function and coronary arteries. The goal of the MASS IV-DM Trial is to achieve a long-term evaluation of the development of coronary atherosclerosis by using angiograms and coronary-artery calcium scan by electron-beam computed tomography at baseline and after 5 years of follow-up. In addition, the incidence of major cardiovascular events, the dysfunction of various organs involved in this disease, particularly microalbuminuria and renal function, will be analyzed through clinical evaluation. In addition, an effort will be made to investigate in depth the presence of major cardiovascular risk factors, especially the biochemical profile, metabolic syndrome inflammatory activity, oxidative stress, endothelial function, prothrombotic factors, and profibrinolytic and platelet activity. An evaluation will be made of the polymorphism as a determinant of disease and its possible role in the genesis of micro- and macrovascular damage.

Discussion

The MASS IV-DM trial is designed to include diabetic patients with clinically suspected myocardial ischemia in whom conventional angiography shows angiographically normal coronary arteries. The result of extensive investigation including angiographic follow-up by several methods, vascular reactivity, pro-thrombotic mechanisms, genetic and biochemical studies may facilitate the understanding of so-called micro- and macrovascular disease of DM.