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Open Access Study protocol

Hypotheses, rationale, design, and methods for prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifest myocardial infarction. A comparative analysis of biomarkers and cardiac magnetic resonance. The MASS-V Trial

Whady Hueb13*, Bernard J Gersh2, Paulo Cury Rezende1, Cibele Larrosa Garzillo1, Eduardo Gomes Lima1, Ricardo D'Oliveira Vieira1, Rosa Maria Rahmi Garcia1, Desiderio Favarato1, Carlos Alexandre W Segre1, Alexandre Costa Pereira1, Paulo Rogério Soares1, Expedito Ribeiro1, Pedro Lemos1, Marco A Perin1, Célia Cassaro Strunz1, Luis AO Dallan1, Fabio B Jatene1, Noedir AG Stolf1, Alexandre Ciappina Hueb1, Ricardo Dias1, Fabio A Gaiotto1, Leandro Menezes Alves da Costa1, Fernando Teiichi Costa Oikawa1, Rodrigo Morel Vieira de Melo1, Carlos Vicente Serrano1, Luiz Francisco Rodrigues de Ávila1, Alexandre Volney Villa1, José Rodrigues Parga Filho1, César Nomura1, José AF Ramires1, Roberto Kalil Filho1 and The MASS-V Study Group

Author Affiliations

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

2 Mayo Clinic, Rochester, MN, USA

3 Av. Dr. Enéas de Carvalho Aguiar 44 AB - 114 Cerqueira César, São Paulo-SP, 05403-000, Brazil

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BMC Cardiovascular Disorders 2012, 12:65  doi:10.1186/1471-2261-12-65

Published: 16 August 2012

Abstract

Background

Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis.

Methods/Design

The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR.

Discussion

The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.

Keywords:
Cardiopulmonary bypass; Necrosis markers; Myocardial infarction; PCI; CABG