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

BMC Cardiovascular Disorders

Study Protocol

Roberto Kalil Filho¹  Paulo Cury Rezende¹  Ricardo D'Oliveira Vieira¹  Carlos Vicente Serrano¹  Alexandre Costa Pereira¹  José Rodrigues Parga Filho¹  Cibele Larrosa Garzillo¹  Ricardo Dias¹  Desiderio Favarato¹  Rosa Maria Rahmi Garcia¹  Fabio B Jatene¹  César Nomura¹  Marco A Perin¹  Leandro Menezes Alves da Costa¹  Fabio A Gaiotto¹  Alexandre Volney Villa¹  Paulo Rogério Soares¹  Alexandre Ciappina Hueb¹  Rodrigo Morel Vieira de Melo¹  Fernando Teiichi Costa Oikawa¹  Expedito Ribeiro¹  Célia Cassaro Strunz¹  José AF Ramires¹  Pedro Lemos¹  Luiz Francisco Rodrigues de Ávila¹  Noedir AG Stolf¹  Luis AO Dallan¹  Eduardo Gomes Lima¹  Carlos Alexandre W Segre¹  Whady Hueb²  Bernard J Gersh³ 

[1] From the Heart Institute of the University of São Paulo, São Paulo, Brazil;From the Heart Institute of the University of São Paulo, São Paulo, Brazil;Av. Dr. Enéas de Carvalho Aguiar 44 AB - 114 Cerqueira César, 05403-000, São Paulo, SP, Brazil;Mayo Clinic, Rochester, MN, USA;

关键词: Cardiopulmonary bypass;    Necrosis markers;    Myocardial infarction;    PCI;    CABG;   

DOI  :  10.1186/1471-2261-12-65

 received in 2012-05-15, accepted in 2012-08-01,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundAlthough 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/DesignThe 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.DiscussionThe 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.

【 授权许可】

CC BY   
© Hueb et al.; licensee BioMed Central Ltd. 2012