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Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI) (LIPSIA STEMI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00359918
First Posted: August 3, 2006
Last Update Posted: August 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Leipzig
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction Drug: fibrinolysis Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • Infarct size and microvascular obstruction assessed by MRI [ Time Frame: 1-6 days ]

Secondary Outcome Measures:
  • Clinical endpoints (bleeding, death, Re-MI, stroke)
  • ST-segment resolution

Enrollment: 162
Study Start Date: August 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359918


Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Principal Investigator: Holger Thiele, MD, PhD Heartcenter Leipzig GmbH
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Leipzig, Heart Center Leipzig
ClinicalTrials.gov Identifier: NCT00359918     History of Changes
Other Study ID Numbers: Reg.-Nr. 008/2006
First Submitted: August 1, 2006
First Posted: August 3, 2006
Last Update Posted: August 7, 2009
Last Verified: August 2009

Keywords provided by University of Leipzig:
infarction
facilitated PCI
primary PCI
infarct size
fibrinolysis
ST-elevation myocardial infarction (STEMI)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases