Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359918
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2006-08-01
Brief Title:
Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention PCI Versus Primary PCI in ST-segment-Elevation MI STEMI
Sponsor:
Holger Thiele
Organization:
University of Leipzig
Study Overview
Official Title:
Randomized Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIPSIA 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
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
Patients undergo cardiac magnetic resonance for assessment of infarct size early at day 1-4 after randomization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None