Status:
COMPLETED
Myocardial Stem Cell Administration After Acute Myocardial Infarction (MYSTAR) Study
Lead Sponsor:
Medical University of Vienna
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The MYocardial STem cell Administration after acute myocardial infaRction (MYSTAR) study is a multicenter, prospective, randomized, single-blind clinical trial designed to compare the early and late i...
Detailed Description
Previous data suggest that bone marrow-derived stem cells (BM-SCs) decrease the infarct size and beneficially affect the postinfarction remodeling. The MYocardial STem cell Administration after acute...
Eligibility Criteria
Inclusion
- Patient with a definitive AMI not earlier than 21 days and not later than 42 days before randomization (day 0 is the day of infarction)
- Patients with open IRA without significant stenosis and TIMI flow 3, after successful percutaneous coronary intervention (PCI) of the IRA
- Patients with two- or three-vessel disease might be included after adequate PCI if no significant coronary lesion can be seen in the non-infarct-related major vessels at the time of BM-SCs therapy
- A persistent local new wall motion abnormality related to the recent infarct location.
- Preserved myocardial viability, at least in the part of the recent infarction should be demonstrated by a preserved wall thickness and/or hypokinesia determined by transthoracic echocardiography or contrast ventriculography, and preserved tracer uptake determined by early and late resting Thallium myocardial scintigraphy or FDG-PET.
- Global LVEF between 30 and 45%.
- Written informed consent.
Exclusion
- Previous heart surgery
- Small posterior or inferior AMI
- Previous MI at the same location
- Regional wall motion abnormality outside the area involved in the index AMI
- Ventricular thrombus
- Severe valvular heart disease
- Severe renal, lung and liver disease
- Disease of the hematopoetic system
- Hemoglobin level below 9 mg%
- The patient cannot follow the study protocol
- NYHA functional class IV at baseline
- Postinfarct angina
- Significant coronary stenosis in the IRA requiring repeated PCI at the time of the planned BM-SCs therapy
- Significant coronary lesion in one or more major coronary vessels, requiring revascularization
- Age lower than 18 years
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00384982
Start Date
January 1 2005
End Date
August 1 2008
Last Update
January 22 2010
Active Locations (1)
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1
Department of Cardiology, Medical University of Vienna
Vienna, Austria, 1090