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

Ibáñez, Borja; Fuster, Valentín; Macaya, Carlos; Sánchez-Brunete, Vicente; Pizarro, Gonzalo; López-Romero, Pedro; Mateos, Alonso; Jiménez-Borreguero, Luis Jesús; Fernández‐Ortíz, Antonio; Sanz, Ginés; Fernández‐Friera, Leticia; Corral, Ervigio; Barreiro, Maria-Victoria; Ruiz-Mateos, Borja; Goicolea, Javier; Hernández‐Antolín, Rosana; Acebal, Carlos; Garcı́a-Rubira, Juan C.; Albarrán, Agustín; Zamorano, José Luís; Casado, Isabel; Valenciano, Juan; Fernández‐Vázquez, Felipe; Torre, José María de la; Prado, Armando Pérez de; Iglesias-Vázquez, José Antonio; Martínez-Tenorio, Pedro; Íñiguez, Andrés

doi:10.1016/j.ahj.2012.07.020

Cited by 38 publications

(37 citation statements)

References 30 publications

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“…16 The Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction (METOCARD-CNIC) trial was a multicenter, randomized, parallel-group, single-blinded (to outcome evaluators) clinical trial in STEMI patients comparing pre-reperfusion intravenous metoprolol and no pre-reperfusion metoprolol (control). The primary hypothesis of the trial was that anterior STEMI patients receiving early intravenous metoprolol before reperfusion would have a reduced infarct size compared with control subjects.…”

Section: Methodsmentioning

confidence: 99%

“…Sample size calculation was based on a previous MRIbased study reporting mean infarct size and dispersion in anterior STEMI patients. 20 To compensate for ≈20% patients not undergoing MRI, 16 we planned to recruit ≈275 patients. All randomized patients, including those not undergoing MRI, were analyzed for clinical end points.…”

Section: Methodsmentioning

confidence: 99%

“…Patients on long-term β-blocker treatment, with a history of previous acute myocardial infarction, or with no final diagnosis of acute myocardial infarction (no enzymatic evidence of infarction) were excluded from the primary analysis according to the protocol and thus did not undergo MRI. 16 …”

Section: Patient Selection and Randomizationmentioning

confidence: 99%

“…To ensure that all patients underwent reperfusion within 6 hours from symptom onset, the inclusion criterion was ≤4.5 hours from symptom onset to randomization. 16 Exclusion criteria were Killip class III to IV acute myocardial infarction, systolic blood pressure persistently <120 mm Hg, PR interval >240 milliseconds (or type II-III atrioventricular block), heart rate persistently <60 bpm, or active treatment with any β-blocker agent.…”

Section: Patient Selection and Randomizationmentioning

confidence: 99%

“…16 Analyses were undertaken by the core laboratory at Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC). Data were quantified with dedicated software (QMass MR 7.5; Medis, Leiden, the Netherlands).…”

Section: Mri Performance and Analysismentioning

confidence: 99%

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Effect of Early Metoprolol on Infarct Size in ST-Segment–Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

et al. 2013

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Background-The effect of β-blockers on infarct size when used in conjunction with primary percutaneous coronary intervention is unknown. We hypothesize that metoprolol reduces infarct size when administered early (intravenously before reperfusion). Methods and Results-Patients with Killip class II or less anterior ST-segment-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention within 6 hours of symptoms onset were randomized to receive intravenous metoprolol (n=131) or not (control, n=139) before reperfusion. All patients without contraindications received oral metoprolol within 24 hours. The predefined primary end point was infarct size on magnetic resonance imaging performed 5 to 7 days after STEMI. Magnetic resonance imaging was performed in 220 patients (81%). Mean±SD infarct size by magnetic resonance imaging was smaller after intravenous metoprolol compared with control (25.6±15.3 versus 32.0±22.2 g; adjusted difference, −6.52; 95% confidence interval, −11.39 to −1.78; P=0.012). In patients with pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction grade 0 to 1 flow, the adjusted treatment difference in infarct size was −8.13 (95% confidence interval, −13.10 to −3.16; P=0.0024). Infarct size estimated by peak and area under the curve creatine kinase release was measured in all study populations and was significantly reduced by intravenous metoprolol. Left ventricular ejection fraction was higher in the intravenous metoprolol group (adjusted difference, 2.67%; 95% confidence interval, 0.09-5.21; P=0.045). The composite of death, malignant ventricular arrhythmia, cardiogenic shock, atrioventricular block, and reinfarction at 24 hours in the intravenous metoprolol and control groups was 7.1% and 12.3%, respectively (P=0.21). Conclusions-In patients with anterior Killip class II or less ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, early intravenous metoprolol before reperfusion reduced infarct size and increased left ventricular ejection fraction with no excess of adverse events during the first 24 hours after STEMI.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Patient Selection and Randomizationmentioning

confidence: 99%

Section: Patient Selection and Randomizationmentioning

confidence: 99%

Section: Mri Performance and Analysismentioning

confidence: 99%

See 3 more Smart Citations

Effect of Early Metoprolol on Infarct Size in ST-Segment–Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

et al. 2013

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Beta-blockers for suspected or diagnosed acute myocardial infarction

Feinberg

Safi

Sethi

et al. 2019

Cochrane Database of Systematic Reviews

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BackgroundCardiovascular disease is the number one cause of death globally. According to the World Health Organization, 7.4 million people died from ischaemic heart diseases in 2012, constituting 15% of all deaths. Acute myocardial infarction is caused by blockage of the blood supplied to the heart muscle. Beta-blockers are o en used in patients with acute myocardial infarction. Previous meta-analyses on the topic have shown conflicting results ranging from harms, neutral e ects, to benefits. No previous systematic review using Cochrane methodology has assessed the e ects of beta-blockers for acute myocardial infarction. ObjectivesTo assess the benefits and harms of beta-blockers compared with placebo or no intervention in people with suspected or diagnosed acute myocardial infarction. Search methodsWe searched CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded and BIOSIS Citation Index in June 2019. We also searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, Turning Research into Practice, Google Scholar, SciSearch, and the reference lists of included trials and previous reviews in August 2019. Selection criteriaWe included all randomised clinical trials assessing the e ects of beta-blockers versus placebo or no intervention in people with suspected or diagnosed acute myocardial infarction. Trials were included irrespective of trial design, setting, blinding, publication status, publication year, language, and reporting of our outcomes. Data collection and analysisWe followed the Cochrane methodological recommendations. Four review authors independently extracted data. Our primary outcomes were all-cause mortality, serious adverse events according to the International Conference on Harmonization -Good Clinical Practice (ICH-GCP), and major adverse cardiovascular events (composite of cardiovascular mortality and non-fatal myocardial infarction during followup). Our secondary outcomes were quality of life, angina, cardiovascular mortality, and myocardial infarction during follow-up. Our primary time point of interest was less than three months a er randomisation. We also assessed the outcomes at maximum follow-up beyond three months. Due to risk of multiplicity, we calculated a 97.5% confidence interval (CI) for the primary outcomes and a 98% CI for the Beta-blockers for suspected or diagnosed acute myocardial infarction (Review)

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Coronary Heart Disease

Smith

Ruiz

2002

Chronic Physical Disorders

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Background-The effect of β-blockers on infarct size when used in conjunction with primary percutaneous coronary intervention is unknown. We hypothesize that metoprolol reduces infarct size when administered early (intravenously before reperfusion). Methods and Results-Patients with Killip class II or less anterior ST-segment-elevation myocardial infarction (STEMI)undergoing percutaneous coronary intervention within 6 hours of symptoms onset were randomized to receive intravenous metoprolol (n=131) or not (control, n=139) before reperfusion. All patients without contraindications received oral metoprolol within 24 hours. The predefined primary end point was infarct size on magnetic resonance imaging performed 5 to 7 days after STEMI. Magnetic resonance imaging was performed in 220 patients (81%). Mean±SD infarct size by magnetic resonance imaging was smaller after intravenous metoprolol compared with control (25.6±15.3 versus 32.0±22.2 g; adjusted difference, −6.52; 95% confidence interval, −11.39 to −1.78; P=0.012). In patients with pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction grade 0 to 1 flow, the adjusted treatment difference in infarct size was −8.13 (95% confidence interval, −13.10 to −3.16; P=0.0024). Infarct size estimated by peak and area under the curve creatine kinase release was measured in all study populations and was significantly reduced by intravenous metoprolol. Left ventricular ejection fraction was higher in the intravenous metoprolol group (adjusted difference, 2.67%; 95% confidence interval, 0.09-5.21; P=0.045). The composite of death, malignant ventricular arrhythmia, cardiogenic shock, atrioventricular block, and reinfarction at 24 hours in the intravenous metoprolol and control groups was 7.1% and 12.3%, respectively (P=0.21). Conclusions-In patients with anterior Killip class II or less ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, early intravenous metoprolol before reperfusion reduced infarct size and increased left ventricular ejection fraction with no excess of adverse events during the first 24 hours after STEMI.

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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

Cited by 38 publications

References 30 publications

Effect of Early Metoprolol on Infarct Size in ST-Segment–Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

Effect of Early Metoprolol on Infarct Size in ST-Segment–Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention

Beta-blockers for suspected or diagnosed acute myocardial infarction

Coronary Heart Disease

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