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…
ID
Bron
Verkorte titel
Aandoening
Acute Myocardioal infarction, rescue PCI, prehospital treatment.
Myocard infarkt
Hartinfarkt
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Infarct size as measured by MRI 1 month post MI.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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"
Onderzoeksopzet
1. Acute phase;
2. During hospitalization;
3. 30 day's;
4. 1 year.
Onderzoeksproduct en/of interventie
5 mg intravenous Metoprolol or matching placebo before reperfusion in the ambulance.
Publiek
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Wetenschappelijk
Sonja Postma
Zwolle 8025 AZ
The Netherlands
+31 (0)38 4262999
s.postma@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2455 |
| NTR-old | NTR2572 |
| Ander register | EudraCT : 2010-023394-19 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |