Early Beta blocker Administration before reperfusion in patients with a myocardial infarction who are planned to undergo a percutaneous coronary intervention within 12 hours

• Conditions: Patients with acute ST elevation myocardial infarction, scheduled for emergency coronary angioplasty; MedDRA version: 16.1Level: LLTClassification code 10066641Term: Acute myocardial infarction, of anterior wallSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: LLTClassification code 10068109Term: Anterolateral myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: LLTClassification code 10000918Term: Acute myocardial infarction, of other specified sites, initial episode of careSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: PTClassification code 10028596Term: Myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: LLTClassification code 10066673Term: Transmural myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: LLTClassification code 10067273Term: Acute transmural myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 16.1Level: LLTClassification code 10028597Term: Myocardial infarction acuteSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2010-023394-19-ES
• Lead Sponsor: Maatschap Cardiologie Isala klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-05
• Last Update Posted: 24 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

Patients ? 18 years of age with symptoms of acute ST-elevation myocardial infarction of more than 30 min but less than 12 h and ST-segment elevation of more than 1 mV in two adjacent electrocardiograph (ECG) leads.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 204

Exclusion Criteria

Severe Hypotension (systolic blood pressure 90 mmHg)
Cardiogenic shock
Severe Asthma
Severe bradycardia (<50 bpm)
Previous myocardial infarction
Unable to provide informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously and additional a second bolus of 5 mg in cathlab before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to undergo primary PCI (PCI);Secondary Objective: Troponin-T after 24 hour of hospitalization<br>Peak CK within hospitalization period<br>Area under CK and CK-MB curve within hospitalization period.<br>Residual ST deviation 1 hr after CAG/PCI<br>Ventricular Fibrillation requiring defibrillation during transportation and hospitalisation<br>MACE at 30 days and one year FUP<br>Safety End Points<br>The incidence of severe bradycardia, asthma or cardiogenic shock<br>30 day and one year total Mortality;Primary end point(s): Infarct size as measured by MRI.;Timepoint(s) of evaluation of this end point: 1 month after the myocardial infarction

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Troponin-T after 24 hour of hospitalization<br>Peak CK within hospitalization period<br>Area under CK and CK-MB curve within hospitalization period.<br>Residual ST deviation 1 hr after CAG/PCI<br>Ventricular Fibrillation requiring defibrillation during<br>transportation and hospitalization<br>MACE at 30 days and one year FUP;Timepoint(s) of evaluation of this end point: Hospitalization and 30 day fup and one year fup