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The purpose of the study is to evaluate whether FX06 is capable of limiting infarct size following balloon catheterization for acute myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 400 mg injected in 2 divided boluses |
|
| 2 | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FX06 | Drug | 400 mg as intravenous injection in two divided boluses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size as measured by cardiac MRI | 5-7 days post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial scar mass and left ventricular function | 4 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Atar, MD | Aker University Hospital, Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Wien | Vienna | A-1090 | Austria | |||
| Wilhelminen-Spital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21062778 | Derived | Hallen J, Jensen JK, Fagerland MW, Jaffe AS, Atar D. Cardiac troponin I for the prediction of functional recovery and left ventricular remodelling following primary percutaneous coronary intervention for ST-elevation myocardial infarction. Heart. 2010 Dec;96(23):1892-7. doi: 10.1136/hrt.2009.190819. | |
| 20542780 | Derived |
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| Percutaneous coronary intervention |
| Procedure |
|
| Vienna |
| A-1171 |
| Austria |
| Academisch Ziekenhuis van de vrije Universiteit | Brussels | B-1090 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | B-1200 | Belgium |
| I. Interna Klinika, Fakultni nemocnice Hradec Kralove | Hradec Králové | CZ-50005 | Czechia |
| Kardiologicke oddeleni, Masarykova nemocnice | Ústí nad Labem | 40013 | Czechia |
| Amtssygehuset i Gentofte | Hellerup | DK-2900 | Denmark |
| Universitätsklinikum Aachen | Aachen | D-52057 | Germany |
| Zentralkliniken Bad Berka | Bad Berka | D-99437 | Germany |
| Charite, Campus Benjamin Franklin | Berlin | D-12200 | Germany |
| Vivantes Klinikum Neukölln, Klinik für Innere Medizin | Berlin | D-13436 | Germany |
| Ev. Freikirchliches KH Bernau und Herzzentrum Brandenburg | Bernau | D-16321 | Germany |
| Krankenhaus Düren gem. GmbH, Innere I (Kardiologie) | Düren | D-52351 | Germany |
| Universitätsklinikum Freiburg - Innere Medizin III | Freiburg im Breisgau | D-79106 | Germany |
| Krankenhaus Martha-Maria Halle-Dölau - Innere Medizin I | Halle | D-06120 | Germany |
| Martin-Luther-Universität Halle-Wittenberg, Klinikum der Medizinischen Fakultät, Inner Medizin III | Halle | D-06120 | Germany |
| Universitätsklinikum Schleswig-Holstein-Klinik f. Kardiologie | Kiel | D-24105 | Germany |
| Universität Leipzig, Klinik für Innere Medizin, Herzzentrum | Leipzig | D-04289 | Germany |
| Universitätsklinikum Schleswig-Holstein,Medizinische Klinik II, Campus Lübeck | Lübeck | D-23538 | Germany |
| Universitätsklinikum Mannheim, I. Medizinische Klinik | Mannheim | D-66167 | Germany |
| Deutsches Herzzentrum München | Munich | D-80636 | Germany |
| Klinik für Innere Medizin und Kardiologie, Marienhospital Osnabrück, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover | Osnabrück | D-49074 | Germany |
| Vilnius University Hospital "Santariskiu klinikos", Center of Cardiology and Angiology | Vilnius | 08661 | Lithuania |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | NL-1091AC | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | NL-3430 EM | Netherlands |
| Krakowski Szpital Specjalistyczny im. Jana Pawla II | Krakow | PL-02507 | Poland |
| Zaklad Szybkiej Diagnostyki, Kardiologicznej, Szpital im. Biekalskiego | Lodz | 91-347 | Poland |
| Samodzielny Publiczy, Zaklad Opieki Zrowotnej, Uniwersytecki Szpital Kliniczny Nr. 3, Im. dr Seweryna Sterlinga | Lodz | 91-425 | Poland |
| Institute for Cardiovascular Disease | Timișoara | 300310 | Romania |
| Sahlgrenska Universitetssjukhuset | Gothenburg | S-41345 | Sweden |
| Universitetssjukhuset | Linköping | S-58185 | Sweden |
| Universitätshospital Zürich | Zurich | CH-8006 | Switzerland |
| Hallen J, Petzelbauer P, Schwitter J, Geudelin B, Buser P, Atar D. Impact of time to therapy and presence of collaterals on the efficacy of FX06 in acute ST elevation myocardial infarction: a substudy of the F.I.R.E., the Efficacy of FX06 in the prevention of myocardial reperfusion injury trial. EuroIntervention. 2010 Apr;5(8):946-52. |
| 19232907 | Derived | Atar D, Petzelbauer P, Schwitter J, Huber K, Rensing B, Kasprzak JD, Butter C, Grip L, Hansen PR, Suselbeck T, Clemmensen PM, Marin-Galiano M, Geudelin B, Buser PT; F.I.R.E. Investigators. Effect of intravenous FX06 as an adjunct to primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction results of the F.I.R.E. (Efficacy of FX06 in the Prevention of Myocardial Reperfusion Injury) trial. J Am Coll Cardiol. 2009 Feb 24;53(8):720-9. doi: 10.1016/j.jacc.2008.12.017. |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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