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.
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 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.


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.


METHODS
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.
Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain. bibanez@cnic.es
Borja
B
Ibanez
Valentin
V
Fuster
Carlos
C
Macaya
Vicente
V
Sánchez-Brunete
Gonzalo
G
Pizarro
Pedro
P
López-Romero
Alonso
A
Mateos
Jesús
J
Jiménez-Borreguero
Antonio
A
Fernández-Ortiz
Ginés
G
Sanz
Leticia
L
Fernández-Friera
Ervigio
E
Corral
Maria-Victoria
MV
Barreiro
Borja
B
Ruiz-Mateos
Javier
J
Goicolea
Rosana
R
Hernández-Antolín
Carlos
C
Acebal
Juan Carlos
JC
García-Rubira
Agustín
A
Albarrán
José Luis
JL
Zamorano
Isabel
I
Casado
Juan
J
Valenciano
Felipe
F
Fernández-Vázquez
José María
JM
de la Torre
Armando
A
Pérez de Prado
José Antonio
JA
Iglesias-Vázquez
Pedro
P
Martínez-Tenorio
Andrés
A
Iñiguez
D000284:Administration, Oral; D058671:Adrenergic beta-1 Receptor Antagonists / Q000008:administration & dosage*; D056988:Anterior Wall Myocardial Infarction / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D006801:Humans; D007262:Infusions, Intravenous / Q000379:methods; D008279:Magnetic Resonance Imaging; D008790:Metoprolol / Q000008:administration & dosage*; D015425:Myocardial Reperfusion; D016037:Single-Blind Method; D013318:Stroke Volume
D058671:Adrenergic beta-1 Receptor Antagonists; D008790:Metoprolol