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The aim of the study is to investigate whether infusion of autologous bone marrow derived stem cells can improve cardiac function in the aftermath of a myocardial infarction.
Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function.
The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary catherization and stem cell infusion | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety |
| Measure | Description | Time Frame |
|---|---|---|
| Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malthe AM Kristiansen, MD | Contact | +45 65504081 | mkristiansen@health.sdu.dk |
| Name | Affiliation | Role |
|---|---|---|
| Moustapha Kassem, MD, Ph.D | Department of endocrinology M, Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of endocrinology M, Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15246726 | Background | Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet. 2004 Jul 10-16;364(9429):141-8. doi: 10.1016/S0140-6736(04)16626-9. | |
| 15489105 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Background |
| Schachinger V, Assmus B, Britten MB, Honold J, Lehmann R, Teupe C, Abolmaali ND, Vogl TJ, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final one-year results of the TOPCARE-AMI Trial. J Am Coll Cardiol. 2004 Oct 19;44(8):1690-9. doi: 10.1016/j.jacc.2004.08.014. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |