Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)
- Conditions
- Myocardial Infarction
- Interventions
- Drug: fibrinolysisProcedure: Primary PCI
- Registration Number
- NCT00359918
- Lead Sponsor
- Holger Thiele
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 162
- Angina pectoris < 3 hours
- ST-elevation myocardial infarction
- Active bleeding
- Active gastric ulcus
- Previous stroke
- Uncontrolled hypertension (> 200 mmHg)
- Cerebral surgery < 8 weeks
- Major surgery < 4 weeks
- Malignancy
- Treatment with coumarines
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehospital facilitated PCI fibrinolysis - Primary PCI Primary PCI -
- Primary Outcome Measures
Name Time Method Infarct size and microvascular obstruction assessed by MRI 1-6 days
- Secondary Outcome Measures
Name Time Method ST-segment resolution 90 min Clinical endpoints (bleeding, death, Re-MI, stroke) 30 days
Trial Locations
- Locations (1)
University of Leipzig - Heart Center
🇩🇪Leipzig, Germany