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 oRiassunto |
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.
Il testo completo di questo articolo è disponibile in PDF.Mappa
| NCT01311700. |
Vol 164 - N° 4
P. 473 - Ottobre 2012 Ritorno al numero
Articolo precedente
- Saphenous vein graft percutaneous coronary intervention via radial artery access: Safe and effective with reduced hospital length of stay
- Shantu S. Bundhoo, Eleanor Earp, Taida Ivanauskiene, Vijay Kunadian, Phillip Freeman, Richard Edwards, Tim D. Kinnaird, Azfar Zaman, Richard A. Anderson
- Pediatric cardiovascular safety: Challenges in drug and device development and clinical application
- Katherine E. Bates, Victoria L. Vetter, Jennifer S. Li, Susan Cummins, Fernando Aguel, Christopher Almond, Anne M. Dubin, Josephine Elia, John Finkle, Elizabeth A. Hausner, Francesca Joseph, Abraham M. Karkowsky, Matthew Killeen, Jodi Lemacks, Lisa Mathis, Ann W. McMahon, Ellen Pinnow, Ignacio Rodriguez, Norman L. Stockbridge, Margaret Stockwell, Melissa Tassinari, Mitchell W. Krucoff
Benvenuto su EM|consulte, il riferimento dei professionisti della salute.
L'accesso al testo integrale di questo articolo richiede un abbonamento.
Già abbonato a @@106933@@ rivista ?