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American heart journal · Oct 2012
Randomized Controlled Trial Multicenter StudyStudy design for the "effect of METOprolol in CARDioproteCtioN during an acute myocardial InfarCtion" (METOCARD-CNIC): a randomized, controlled parallel-group, observer-blinded clinical trial of early pre-reperfusion metoprolol administration in ST-segment elevation myocardial infarction.
- Borja Ibanez, Valentin Fuster, Carlos Macaya, Vicente Sánchez-Brunete, Gonzalo Pizarro, Pedro López-Romero, Alonso Mateos, Jesús Jiménez-Borreguero, Antonio Fernández-Ortiz, Ginés Sanz, Leticia Fernández-Friera, Ervigio Corral, Maria-Victoria Barreiro, Borja Ruiz-Mateos, Javier Goicolea, Rosana Hernández-Antolín, Carlos Acebal, Juan Carlos García-Rubira, Agustín Albarrán, José Luis Zamorano, Isabel Casado, Juan Valenciano, Felipe Fernández-Vázquez, José María de la Torre, Armando Pérez de Prado, José Antonio Iglesias-Vázquez, Pedro Martínez-Tenorio, and Andrés Iñiguez.
- Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain. bibanez@cnic.es
- Am. Heart J. 2012 Oct 1;164(4):473-480.e5.
BackgroundInfarct size predicts post-infarction mortality. Oral β-blockade within 24 hours of a ST-segment elevation acute myocardial infarction (STEMI) is a class-IA indication, however early intravenous (IV) β-blockers initiation is not encouraged. In recent magnetic resonance imaging (MRI)-based experimental studies, the β(1)-blocker metoprolol has been shown to reduce infarct size only when administered before coronary reperfusion. To date, there is not a single trial comparing the pre- vs. post-reperfusion β-blocker initiation in STEMI.ObjectiveThe METOCARD-CNIC trial is testing whether the early initiation of IV metoprolol before primary percutaneous coronary intervention (pPCI) could reduce infarct size and improve outcomes when compared to oral post-pPCI metoprolol initiation.DesignThe METOCARD-CNIC trial is a randomized parallel-group single-blind (to outcome evaluators) clinical effectiveness trial conducted in 5 Counties across Spain that will enroll 220 participants. Eligible are 18- to 80-year-old patients with anterior STEMI revascularized by pPCI ≤6 hours from symptom onset. Exclusion criteria are Killip-class ≥III, atrioventricular block or active treatment with β-blockers/bronchodilators. Primary end point is infarct size evaluated by MRI 5 to 7 days post-STEMI. Prespecified major secondary end points are salvage-index, left ventricular ejection fraction recovery (day 5-7 to 6 months), the composite of (death/malignant ventricular arrhythmias/reinfarction/admission due to heart failure), and myocardial perfusion.ConclusionsThe METOCARD-CNIC trial is testing the hypothesis that the early initiation of IV metoprolol pre-reperfusion reduces infarct size in comparison to initiation of oral metoprolol post-reperfusion. Given the implications of infarct size reduction in STEMI, if positive, this trial might evidence that a refined use of an approved inexpensive drug can improve outcomes of patients with STEMI.Copyright © 2012 Mosby, Inc. All rights reserved.
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