Acute Myocardial Infarction, Early Left Ventricular Dysfunction
Conditions
Brief summary
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.
Interventions
PROCEDUREPercutaneous Coronary Intervention
common Percutaneous Coronary Intervention
PROCEDUREBMNC therapy
Injection of BMNC after common PCI
Sponsors
Asklepios proresearch
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 * pregancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF). | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed