No registrations found.
ID
Source
Brief title
Health condition
Acute Myocardioal infarction, rescue PCI, prehospital treatment.
Myocard infarkt
Hartinfarkt
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infarct size as measured by MRI 1 month post MI.
Secondary outcome
1. Troponin-T after 24 hour of hospitalization
2. Peak CK within hospitalization period
3. Area under CK and CK-MB curve within hospitalization period.
4. Residual ST deviation 1 hr after CAG/PCI
5. Ventricular Fibrillation requiring defibrillation during transportation and hospitalization
6. MACE at 30 days and one year FUP
Safety End Points:
1. The incidence of severe bradycardia, asthma or cardiogenic shock
2. 30 day and one year total mortality
Background summary
This study evaluates the beneficial effects of early administration of 5 mg intravenous Metoprolol or placebo before reperfusion in the ambulance in patients with ST elevation myocardial infarction.
Study objective
31-3-2014 Hypothesis: Early administration of 5 mg of Metoprolol is associated with a relative 20% reduction in infarct size as measured by cardiac Troponin-T, a total of 408 patients will be enrolled and randomized. Interventions: 5 mg intravenous Metoprolol or matching placebo before reperfusion. Health problems studied: changed "Prehospital treatment" into "Early treatment"
Study design
1. Acute phase;
2. During hospitalization;
3. 30 day's;
4. 1 year.
Intervention
5 mg intravenous Metoprolol or matching placebo before reperfusion in the ambulance.
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Inclusion criteria
1. 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).
2. Verbal followed by written informed consents.
3. PCI-center located within 90 minutes
Exclusion criteria
1. Severe Hypotension (systolic blood pressure < 100 mmHg)
2. Cardiogenic shock (severe dyspnoea, hypotension and oxygen saturation
<92%, systolic blood pressure < 100 mmHg and heartrate > 110/min)
3. Known with asthma
4. Severe bradycardia at sinusrythm (< 60 bpm)
5. PR interval >240 ms or second- and/or third degree atrio-ventricular (AV) block
6. History of previous myocardial infarction
7. Killip class III-IV
8. Pacemaker/implantable cardioverter defibrillator (ICD)
9. Unable to provide informed consent
10. Patient is pregnant or breastfeeding
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2455 |
| NTR-old | NTR2572 |
| Other | EudraCT : 2010-023394-19 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |