The primary objective of this randomized trial is to assess the beneficial effects of early administration of 5 mg Metoprolol intravenously before reperfusion on infarct size in patients with ST elevation myocardial infarction who are planned to…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infarct size, as measured by MRI one month after the myocardial infarction.
Secondary outcome
- A single Troponin T measured after 24 hours of hospitalization period
- Peak CK within hospitalisation period
- Area under CK and CK-MB curve within hospitalization period
- Residual ST deviation 1 hr after CAG/PCI
- Ventricular fibrillation requiring defibrillation during transportation and
hospitalisation
- MACE at 30 days and one year FUP
Safety End Points:
- The incidence of severe bradycardia, asthma or cardiogenic shock
- 30 day and one year total mortality
Background summary
The management of patients with ST elevation myocardial infarction has
considerably improved over the past decades, with many factors involved in the
reduction of mortality, including early diagnosis and early treatment of the
acute event, improved management of complications such as recurrent ischemia
and heart failure, and general availability of pharmacological therapies (1).
Beta-blockers are keystones in the treatment of patients with an acute coronary
syndromes. Beta-blockers have indisputably been demonstrated to be clinically
useful in the setting of acute myocardial infarction (MI), with a large body of
evidence showing mortality reductions when administered early (2-6).
Beta-blockers also decrease the incidence of re-infarction, recurrent ischemia,
or life-threatening arrhythmias and prevent left ventricular (LV) remodelling
(7-9) Therefore, the use of oral beta-blockade constitutes a class I indication
in clinical practice guidelines (1). However, whether early intravenous
administration of Beta-blockers during the acute phase of MI before reperfusion
is effective in not yet clear. Some preclinical studies suggest that
beta-blockers decrease the extent of necrosis, (10-12) whereas others have
shown no effect (13-15). The results of human clinical studies, mostly
performed in or before the thrombolytic era, also are controversial (4,16-19).
A recent study in a swine MI model, a single dose of Metoprolol during ongoing
MI, before reperfusion, results in 5-fold-larger salvaged myocardium (27%
reduction in MI size). (20).
Therefore, the aim of the current study is to evaluates the beneficial effects
of early administration of 5 mg intravenous Metoprolol or placebo before
reperfusion in the ambulance/ at the HCK and again 5 mg at hospital admission
pre CAG (HCK), in patients with ST elevation myocardial infarction.
Study objective
The primary objective of this randomized trial is to assess the beneficial
effects of early administration of 5 mg Metoprolol intravenously before
reperfusion on infarct size in patients with ST elevation myocardial infarction
who are planned to undergo primary PCI.
Study design
Multi-centre, international, prospective, randomized, double-blind,
placebo-controlled trial
Intervention
Only one or two injection of Metoprolol or Placebo. The PCI, blood tests,
physical examination and other checks are part of the standard treatment for
patients with acute myocardial infarction.
Study burden and risks
The side effects of Metoprolol are: fatigue, dizziness, headache. Low heart
rate and low blood pressure. Nausea, vomiting and abdominal pain are rare.
An MRI scan can do no harm unless patients contain metal objects inside their
body. The contrast fluid can cause a warm feeling and in some patients can lead
to an allergic reaction.
Other risks are related to the heart attack and the usual treatment for this.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2010-023394-19-NL |
| CCMO | NL34300.075.10 |