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Sponsored by: |
University of Zurich |
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Information provided by: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT00355186 |
Title: SWiss multicenter Intracoronary Stem cells Study in Acute Myocardial Infarction (SWISS-AMI).
Study population: Patients with acute myocardial infarction, treated with primary PCI.
Objective: To determine whether intracoronary infusion of BMCs improves recovery of left ventricular function after acute myocardial infarction treated by PCI
Design: Multi-center, randomized, controlled clinical trial with central core lab analysis for MRI.
Therapy: Intracoronary infusion of BMCs in the infarct related artery at 5-7 days or 3-4 weeks after successful primary PCI
Primary Endpoint: Change in global left ventricular ejection fraction (LVEF) at 4 months relative to baseline measured by quantitative MRI.
Secondary Endpoints:
Interventions:
Therapy groups: Bone marrow-derived stem cells infusion in the successfully revascularized infarct related vessel at day 5-7 or day 21-28.
Control group: Management according to the "state of the art" medical therapy after successful primary PCI.
Safety: A study independent "safety committee" will analyze the clinical results after the first 60 patients.
Condition | Intervention | Phase |
---|---|---|
Acute Myocardial Infarction |
Procedure: intracoronary bone marrow cells infusion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI) |
Estimated Enrollment: | 150 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Roberto Corti, MD | 0041 44 255 1111 | roberto.corti@usz.ch |
Switzerland | |
Cardiology, university Hospital Zurich | Recruiting |
Zurich, Switzerland, 8091 | |
Contact: Roberto Corti, MD 0041 44 255 1111 roberto.corti@usz.ch | |
Sub-Investigator: Daniel Surder, MD | |
Cardiocentro Ticino | Recruiting |
Lugano, Switzerland, 6900 | |
Contact: Tiziano Moccetti, MD 0041 91 805 3111 | |
Principal Investigator: Tiziano Moccetti, MD | |
Cardiology, University Hospital Berne | Recruiting |
Bern, Switzerland | |
Contact: Otto M Hess, MD | |
Principal Investigator: Stephan Windecker, MD | |
Kantonsspital | Recruiting |
Lucerne, Switzerland | |
Contact: Paul Erne, Professor |
Principal Investigator: | Roberto Corti, MD | Cardiology, University Hospital Zurich, Switzerland |
Study Chair: | Thomas F Luescher, MD | Cardiology, University Hospital Zurich |
Responsible Party: | University of Zurich ( University of Zurich ) |
Study ID Numbers: | SWISS-AMI |
Study First Received: | July 20, 2006 |
Last Updated: | June 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00355186 |
Health Authority: | Switzerland: Swissmedic |
acute myocardial infarction MRI bone marrow cells stem cells remodeling |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |