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The purpose of this study in patients with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim, PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.
Coronary artery disease (CAD) is the leading cause of death in industrialized countries. Current revascularization therapies are PCI or surgical revascularization. However, inherent to them are procedure-related risks and the fact, that progression of CAD is not prevented. Additionally, up to one fourth of all CAD patients are not amenable to standard revascularization therapies. Thus, there is a need for alternative therapies. The coronary collateral circulation is prevalent in humans, and in CAD the amount of collateral flow is a pivotal protective factor with respect to infarct size, all-cause- and cardiac mortality. Coronary collateral growth promotion is an alternative to conventional revascularization which can be achieved by cytokine-based approaches (e.g. with colony-stimulating factor-therapy) in humans. The goal of collateral promotion is to reduce myocardial damage in case of a coronary occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collateral promotion; PCI after 6 months | Experimental | First pegGCSF or placebo; PCI after 6 months |
|
| Collateral promotion after PCI at baseline | Experimental | Collateral promotion with pegGCSF after PCI at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegfilgrastim | Biological | s.c. administration of pegylated G-CSF over 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collateral flow index (CFI) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial blood flow (MBF) during hyperemia | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Seiler, MD, Prof. | University of Bern | Study Chair |
| Tobias Traupe, MD | University Hospital Berne | Principal Investigator |
| Michael Stoller, MD | University Hospital Berne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Berne | Bern | Canton of Bern | 3010 | Switzerland | ||
| University Hospital Berne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19770393 | Background | Meier P, Gloekler S, de Marchi SF, Indermuehle A, Rutz T, Traupe T, Steck H, Vogel R, Seiler C. Myocardial salvage through coronary collateral growth by granulocyte colony-stimulating factor in chronic coronary artery disease: a controlled randomized trial. Circulation. 2009 Oct 6;120(14):1355-63. doi: 10.1161/CIRCULATIONAHA.109.866269. Epub 2009 Sep 21. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| C486981 | pegylated granulocyte colony-stimulating factor, human |
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|
| Placebo | Other | Placebo control Arm 1: Collateral promotion; PCI after 6 months |
|
|
| Bern |
| 3010 |
| Switzerland |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |