Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)
NCT ID: NCT00359918
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
162 participants
INTERVENTIONAL
2006-08-31
2009-08-31
Brief Summary
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This studies tests the hypothesis that prehospital initiated facilitated PCI is superior to primary percutaneous coronary intervention with respect to infarct size.
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Detailed Description
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Patients undergo cardiac magnetic resonance for assessment of infarct size early at day 1-4 after randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prehospital facilitated PCI
fibrinolysis
Primary PCI
Primary PCI
Primary PCI
Primary PCI
Interventions
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fibrinolysis
Primary PCI
Primary PCI
Primary PCI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ST-elevation myocardial infarction
Exclusion Criteria
* Active gastric ulcus
* Previous stroke
* Uncontrolled hypertension (\> 200 mmHg)
* Cerebral surgery \< 8 weeks
* Major surgery \< 4 weeks
* Malignancy
* Treatment with coumarines
* Pregnancy
18 Years
ALL
No
Sponsors
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Holger Thiele
OTHER
Responsible Party
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Holger Thiele
PI
Principal Investigators
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Holger Thiele, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Heart Center Leipzig - University Hospital
Locations
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University of Leipzig - Heart Center
Leipzig, , Germany
Countries
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References
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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.
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.
Other Identifiers
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Reg.-Nr. 008/2006
Identifier Type: -
Identifier Source: org_study_id
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