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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehospital facilitated PCI | Experimental |
| |
| Primary PCI | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fibrinolysis | Drug | Primary PCI |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size and microvascular obstruction assessed by MRI | 1-6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical endpoints (bleeding, death, Re-MI, stroke) | 30 days | |
| ST-segment resolution | 90 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, MD, PhD | Heart Center Leipzig - University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leipzig - Heart Center | Leipzig | 04289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24962156 | Derived | de Waha S, Eitel I, Desch S, Fuernau G, Lurz P, Stiermaier T, Blazek S, Schuler G, Thiele H. Prognosis after ST-elevation myocardial infarction: a study on cardiac magnetic resonance imaging versus clinical routine. Trials. 2014 Jun 25;15:249. doi: 10.1186/1745-6215-15-249. | |
| 21700245 | Derived | Thiele H, Eitel I, Meinberg C, Desch S, Leuschner A, Pfeiffer D, Hartmann A, Lotze U, Strauss W, Schuler G; LIPSIA-STEMI Trial Group. Randomized comparison of pre-hospital-initiated facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention in acute myocardial infarction very early after symptom onset: the LIPSIA-STEMI trial (Leipzig immediate prehospital facilitated angioplasty in ST-segment myocardial infarction). JACC Cardiovasc Interv. 2011 Jun;4(6):605-14. doi: 10.1016/j.jcin.2011.01.013. |
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| Primary PCI | Procedure | Primary PCI |
|
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D005342 | Fibrinolysis |
| ID | Term |
|---|---|
| D001777 | Blood Coagulation |
| D006487 | Hemostasis |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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