Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)
LIPSIA STEMI
Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial
1 other identifier
interventional
162
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedFirst Posted
Study publicly available on registry
August 3, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedJune 26, 2018
June 1, 2018
3 years
August 1, 2006
June 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infarct size and microvascular obstruction assessed by MRI
1-6 days
Secondary Outcomes (2)
Clinical endpoints (bleeding, death, Re-MI, stroke)
30 days
ST-segment resolution
90 min
Study Arms (2)
Prehospital facilitated PCI
EXPERIMENTALPrimary PCI
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Angina pectoris \< 3 hours
- ST-elevation myocardial infarction
You may not qualify if:
- Active bleeding
- Active gastric ulcus
- Previous stroke
- Uncontrolled hypertension (\> 200 mmHg)
- Cerebral surgery \< 8 weeks
- Major surgery \< 4 weeks
- Malignancy
- Treatment with coumarines
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Holger Thielelead
Study Sites (1)
University of Leipzig - Heart Center
Leipzig, 04289, Germany
Related Publications (2)
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.
PMID: 24962156DERIVEDThiele 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.
PMID: 21700245DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Holger Thiele, MD, PhD
Heart Center Leipzig - University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
August 1, 2006
First Posted
August 3, 2006
Study Start
August 1, 2006
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
June 26, 2018
Record last verified: 2018-06