Status:
COMPLETED
Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)
Lead Sponsor:
University of Ulm
Conditions:
Acute Myocardial Infarction
Coronary Artery Disease
Eligibility:
All Genders
35-75 years
Phase:
PHASE2
Brief Summary
Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlle...
Detailed Description
There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.
Eligibility Criteria
Inclusion
- acute myocardial infarction with time to revascularization \>6 hours from symptom start
- clear target vessel
- large myocardial infarction defined as: proximal vessel occlusion, CK \> 1000 U/L, myocardial scar in magnetic resonance imaging \> 10% of left ventricular muscle mass
- potential prior thrombolysis
- written informed consent
Exclusion
- acute myocardial infarction with revascularization within 6 hours after symptom start
- prior myocardial infarction
- no clear target vessel
- contraindication for magnetic resonance imaging (e.g. pacemaker, ICD)
- severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging)
- prior hematologic disease
- prior chemo therapy
- prior stem cell transplantation
- prior treatment with G-CSF
- known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis
- local infection of puncture sites
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00669227
Start Date
October 1 2005
Last Update
June 10 2014
Active Locations (1)
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1
University of Ulm
Ulm, Germany, 89081