In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) \>30.
After coronary stenting, index of microvascular resistance (IMR) will be measured invasively. Patients with IMR \>30 will be randomised to 20 mg alteplase or placebo (NaCl) administered in the culprit vessel through a microcatheter. Magnet resonance imaging (MRI) of the myocardium will be performed early (2-6 days) and late (3 months) to estimate the primary endpoint (infarct size). 10 non-randomised patients, with IMR \<30, will undergo the same follow-up as the randomised patients. Clinical events for all randomised and non-randomised patients will be collected from Swedish national registries and by telephone at 3 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Department of Cardiology, Sahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGRatio of myocardial infarct size to area at risk assessed by MRI
MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size
Time frame: 3 months
Change of index of microvascular resistance and coronary flow reserve
Difference in invasively measured IMR and CFR before and after drug administration
Time frame: Immediately after drug administration during invasive index procedure
Degree of microvascular obstruction assessed by MRI
Degree of microvascular obstruction assessed by MRI
Time frame: 2-6 days
Peak level of Troponin T
Peak level of Troponin T
Time frame: 12 hours
Level of NtProBNP
Level of NtProBNP
Time frame: 12 hours
Non invasive CFR
CFR measured with transthoracic echo doppler
Time frame: 3 months
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Time frame: 3 months
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
Major adverse cardiac event (myocardial infarction, stroke, heart failure or death)
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Time frame: 12 months
Re-hospitalisation for heart failure
Re-hospitalisation for heart failure
Time frame: 12 months
Re-hospitalisation for myocardial infarction
Re-hospitalisation for myocardial infarction
Time frame: 12 months
Cardiovascular death
Cardiovascular death
Time frame: 12 months
Bleeding according to BARC-criteria
Bleeding events during or after index PCI during index hospitalisation
Time frame: 7 days
Myocardial hemorrhage at MRI
Myocardial hemorrhage at MRI
Time frame: 2-6 days
Change in hemoglobin
Change in hemoglobin
Time frame: 12 hours