Myocardial Infarction
Conditions
Keywords
infarction, facilitated PCI, primary PCI, infarct size, fibrinolysis, ST-elevation myocardial infarction (STEMI)
Brief summary
Prehospital initiated facilitation of primary percutaneous coronary intervention by fibrinolysis might be helpful in re-opening the infarct related artery prior to percutaneous coronary intervention. This studies tests the hypothesis that prehospital initiated facilitated PCI is superior to primary percutaneous coronary intervention with respect to infarct size.
Detailed description
Patients with STEMI with symptoms \< 3 hours are randomized in the region of Leipzig to either prehospital full-dose fibrinolysis (+ASA, Clopidogrel and heparin) with subsequent facilitated percutaneous coronary intervention or to primary percutaneous coronary intervention (after ASA + heparin + clopidogrel). Patients undergo cardiac magnetic resonance for assessment of infarct size early at day 1-4 after randomization.
Interventions
DRUGfibrinolysis
Primary PCI
PROCEDUREPrimary PCI
Primary PCI
Sponsors
Holger Thiele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Angina pectoris \< 3 hours * ST-elevation myocardial infarction
Exclusion criteria
* Active bleeding * Active gastric ulcus * Previous stroke * Uncontrolled hypertension (\> 200 mmHg) * Cerebral surgery \< 8 weeks * Major surgery \< 4 weeks * Malignancy * Treatment with coumarines * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infarct size and microvascular obstruction assessed by MRI | 1-6 days |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints (bleeding, death, Re-MI, stroke) | 30 days |
| ST-segment resolution | 90 min |
Countries
Germany
Outcome results
None listed