NCT00939042TerminatedNot Applicable
Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells
Asklepios proresearch1 site in 1 country40 target enrollmentStarted: January 1, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
Study Overview
Brief Summary
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
- •conventional therapy according to the ESC guidelines for heart failure
- •BMI > 20 and < 35
Exclusion Criteria
- •PCI elder then 21 days
- •relevant valvular disease
- •history of stroke/multivessel disease/thromboembolic event etc.
- •DM Type I
Outcomes
Primary Outcomes
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
Time Frame: 12 months
Secondary Outcomes
- Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.(12 months)
- Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.(12 months)
Investigators
Study Sites (1)
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