Status:
COMPLETED
SWiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial Infarction (SWISS-AMI)
Lead Sponsor:
University of Zurich
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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: ...
Eligibility Criteria
Inclusion
- Visual LVEF at angiogram or echocardiography ≤45%
- Treatment by primary PCI within 24 hours of the onset of chest pain or initial treatment with thrombolysis within the 12 hours followed by PCI within the 24 hours of the onset of chest pain
- Significant regional LV wall motion dysfunction in the infarct related territory
- Age \>18 years
Exclusion
- Abnormal regional wall motion outside the infarct region
- Known previous myocardial infarction in the same target vessel
- Known pre-existing left ventricular dysfunction (EF\<45% prior to admission)
- Need for revascularization in the non infarct-related coronary within 4 months
- Pre-existing symptoms of heart failure or known cardiomyopathy
- Known active infection or chronic infection with HIV, HBV or HCV
- Chronic inflammatory disease
- Serious concomitant disease with a life expectancy of less than one year
- Follow up impossible (no fixed abode, etc)
- Contraindication for cardiac MRI (i.e. pace maker, neurostimulator, claustrophobia)
- Severe renal failure (creatinine \>250 mmol/l)
- Relevant liver disease (GOT \> 2x norm or spontaneous INR \> 1,5)
- Anemia (Hb \< 8.5 mg/dl), Thrombocytopenia (\<100.000/µl)
- Pregnancy
- Participation at a clinical trial in the last 30 days
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00355186
Start Date
August 1 2006
End Date
November 1 2012
Last Update
November 12 2012
Active Locations (4)
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1
Cardiology, University Hospital Berne
Bern, Switzerland
2
Kantonsspital
Lucerne, Switzerland
3
Cardiocentro Ticino
Lugano, Switzerland, 6900
4
Cardiology, university Hospital Zurich
Zurich, Switzerland, 8091