ST-segment Elevation Myocardial Infarction
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGalteplase
DRUGPlacebo
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Criteria for randomization: 1\. IMR measured in culprit vessel \> 30 Criteria for IMR measurement: Inclusion Criteria: 1. Oral and signed informed consent 2. Males and females 18 - 85 years of age 3. Diagnosis of ST-elevation myocardial infarction (STEMI) including occlusion of culprit vessel on angiography 4. Onset of continuous symptoms within 12 hours 5. Have undergone PCI of culprit vessel 6. Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent
Exclusion criteria
1. Previously known ejection fraction \<30% 2. Previous PCI in the culprit vessel 3. Chronic total occlusion in major vessel 4. Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions 5. Recent history or known platelet count \<100.000 cells/mm3 or Hbg \< 10 g/dL 6. Known reduced kidney function with estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m2. 7. Previous hemorrhagic stroke 8. Ongoing oral anticoagulation treatment 9. Severe asthma requiring daily treatment 10. Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade) 11. Atrioventricular block grade III 12. Known inability to undergo MRI investigation Permanent pacemaker * Pronounced claustrophobia 13. Known intolerance to study drug 14. Known intolerance to adenosine 15. Pregnancy 16. Participation in another investigational drug study 17. Previous randomization in the OPTIMAL-PCI trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of myocardial infarct size to area at risk assessed by MRI | 3 months | MRI performed early (day 2-6) to assess area at risk and late (3 months) to assess infarct size |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of NtProBNP | 12 hours | Level of NtProBNP |
| Non invasive CFR | 3 months | CFR measured with transthoracic echo doppler |
| Change of index of microvascular resistance and coronary flow reserve | Immediately after drug administration during invasive index procedure | Difference in invasively measured IMR and CFR before and after drug administration |
| Degree of microvascular obstruction assessed by MRI | 2-6 days | Degree of microvascular obstruction assessed by MRI |
| Major adverse cardiac event (myocardial infarction, stroke, heart failure or death) | 3 months | Major adverse cardiac event (myocardial infarction, stroke, heart failure or death) |
| Peak level of Troponin T | 12 hours | Peak level of Troponin T |
| Re-hospitalisation for myocardial infarction | 12 months | Re-hospitalisation for myocardial infarction |
| Cardiovascular death | 12 months | Cardiovascular death |
| Bleeding according to BARC-criteria | 7 days | Bleeding events during or after index PCI during index hospitalisation |
| Myocardial hemorrhage at MRI | 2-6 days | Myocardial hemorrhage at MRI |
| Change in hemoglobin | 12 hours | Change in hemoglobin |
| Re-hospitalisation for heart failure | 12 months | Re-hospitalisation for heart failure |
Countries
Sweden
Contacts
Primary ContactOskar Angerås, MD, PhD
Outcome results
None listed