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Clinical Trial
. 2012 Aug 16:12:65.
doi: 10.1186/1471-2261-12-65.

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 Hueb  1 , Bernard J Gersh, Paulo Cury Rezende, Cibele Larrosa Garzillo, Eduardo Gomes Lima, Ricardo D'Oliveira Vieira, Rosa Maria Rahmi Garcia, Desiderio Favarato, Carlos Alexandre W Segre, Alexandre Costa Pereira, Paulo Rogério Soares, Expedito Ribeiro, Pedro Lemos, Marco A Perin, Célia Cassaro Strunz, Luis A O Dallan, Fabio B Jatene, Noedir A G Stolf, Alexandre Ciappina Hueb, Ricardo Dias, Fabio A Gaiotto, Leandro Menezes Alves da Costa, Fernando Teiichi Costa Oikawa, Rodrigo Morel Vieira de Melo, Carlos Vicente Serrano Jr, Luiz Francisco Rodrigues de Ávila, Alexandre Volney Villa, José Rodrigues Parga Filho, César Nomura, José A F Ramires, Roberto Kalil Filho; MASS-V Study Group
Collaborators, Affiliations
Clinical Trial

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 Hueb et al. BMC Cardiovasc Disord. .

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.

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Figures

Figure 1
Figure 1
Algorithm of MASS V Trial. Legend: Enrollment and follow-up procedures in the arms of MASS V trial.
See this image and copyright information in PMC

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