Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial
Overview
- Phase
- Phase 4
- Intervention
- Primary PCI
- Conditions
- Myocardial Infarction
- Sponsor
- Holger Thiele
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Infarct size and microvascular obstruction assessed by MRI
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Holger Thiele
PI
University of Leipzig
Eligibility Criteria
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
Arms & Interventions
Primary PCI
Intervention: Primary PCI
Prehospital facilitated PCI
Intervention: fibrinolysis
Outcomes
Primary Outcomes
Infarct size and microvascular obstruction assessed by MRI
Time Frame: 1-6 days
Secondary Outcomes
- ST-segment resolution(90 min)
- Clinical endpoints (bleeding, death, Re-MI, stroke)(30 days)