Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI) (LIPSIA STEMI)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
fibrinolysis
Primary PCI
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring infarction, facilitated PCI, primary PCI, infarct size, fibrinolysis, ST-elevation myocardial infarction (STEMI)
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
Sites / Locations
- University of Leipzig - Heart Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prehospital facilitated PCI
Primary PCI
Arm Description
Outcomes
Primary Outcome Measures
Infarct size and microvascular obstruction assessed by MRI
Secondary Outcome Measures
Clinical endpoints (bleeding, death, Re-MI, stroke)
ST-segment resolution
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00359918
Brief Title
Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)
Acronym
LIPSIA STEMI
Official Title
Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Holger Thiele
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
infarction, facilitated PCI, primary PCI, infarct size, fibrinolysis, ST-elevation myocardial infarction (STEMI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prehospital facilitated PCI
Arm Type
Experimental
Arm Title
Primary PCI
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fibrinolysis
Other Intervention Name(s)
Primary PCI
Intervention Description
Primary PCI
Intervention Type
Procedure
Intervention Name(s)
Primary PCI
Intervention Description
Primary PCI
Primary Outcome Measure Information:
Title
Infarct size and microvascular obstruction assessed by MRI
Time Frame
1-6 days
Secondary Outcome Measure Information:
Title
Clinical endpoints (bleeding, death, Re-MI, stroke)
Time Frame
30 days
Title
ST-segment resolution
Time Frame
90 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD, PhD
Organizational Affiliation
Heart Center Leipzig - University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Leipzig - Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24962156
Citation
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.
Results Reference
derived
PubMed Identifier
21700245
Citation
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.
Results Reference
derived
Learn more about this trial
Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)
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