Early Beta blocker Administration before reperfusion in patients with ST-Elevation Myocardial Infarction who are planned to undergo primary PCI

Phase 3

Completed

Conditions: heart attack
Myocardial infarction
10011082

Registration Number: NL-OMON41647

Lead Sponsor: Maatschap cardiologie Isala

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

• Patients >= 18 years of age with symptoms of acute ST-elevation myocardial infarction of more than 30 min but less than 12 hours and on the ECG ST-segment elevation of >=0.1 mV in two adjacent limb electrocardiograph (ECG) leads and >=0.2 mV in two adjacent precordial ECG leads or new left bundle branch block (LBBB).
• Verbal followed by written informed consents.
• PCI-center located within 90 minutes

Exclusion Criteria

• Severe Hypotension (systolic blood pressure < 100 mmHg)
• Cardiogenic shock (severe dyspnoea, hypotension and oxygen saturation <92%, systolic blood pressure < 100 mmHg and heartrate > 110/min)
• Known with asthma
• Severe bradycardia at sinusrythm (< 60 bpm)
• PR interval >240 ms or second- and/or third degree atrio-ventricular (AV) block
• History of previous myocardial infarction
• Killip class III-IV
• Pacemaker/implantable cardioverter defibrillator (ICD)
• Unable to provide informed consent
• Patient is pregnant or breastfeeding

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Infarct size, as measured by MRI one month after the myocardial infarction.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- A single Troponin T measured after 24 hours of hospitalization period<br /><br>- Peak CK within hospitalisation period<br /><br>- Area under CK and CK-MB curve within hospitalization period<br /><br>- Residual ST deviation 1 hr after CAG/PCI<br /><br>- Ventricular fibrillation requiring defibrillation during transportation and<br /><br>hospitalisation<br /><br>- MACE at 30 days and one year FUP<br /><br><br /><br>Safety End Points:<br /><br>- The incidence of severe bradycardia, asthma or cardiogenic shock<br /><br>- 30 day and one year total mortality</p><br>