Study 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 - 15/10/12
, Valentin Fuster, MD, PhD a, c, Carlos Macaya, MD, PhD b, Vicente Sánchez-Brunete, MD d, Gonzalo Pizarro, MD a, e, Pedro López-Romero, PhD a, Alonso Mateos, MD a, d, Jesús Jiménez-Borreguero, MD a, f, Antonio Fernández-Ortiz, MD, PhD a, b, Ginés Sanz, MD, PhD a, Leticia Fernández-Friera, MD, PhD a, g, Ervigio Corral, MD h, Maria-Victoria Barreiro, MD i, Borja Ruiz-Mateos, MD b, Javier Goicolea, MD, PhD j, Rosana Hernández-Antolín, MD, PhD b, Carlos Acebal, MD b, Juan Carlos García-Rubira, MD, PhD k, Agustín Albarrán, MD l, José Luis Zamorano, MD, PhD m, Isabel Casado, MD h, Juan Valenciano, MD d, Felipe Fernández-Vázquez, MD, PhD n, José María de la Torre, MD, PhD g, Armando Pérez de Prado, MD, PhD n, José Antonio Iglesias-Vázquez, MD, PhD i, Pedro Martínez-Tenorio, MD d, Andrés Iñiguez, MD, PhD oRésumé |
Background |
Infarct 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 β1-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.
Objective |
The 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.
Design |
The 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.
Conclusions |
The 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.
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| NCT01311700. |
Vol 164 - N° 4
P. 473 - octobre 2012 Retour au numéro
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