Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Stable, Coronary Collaterals, Therapeutic Collateral Promotion (TCP)
Brief summary
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.
Detailed description
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.
Interventions
s.c. administration of pegylated G-CSF over 6 months
Placebo control Arm 1: Collateral promotion; PCI after 6 months
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age \> 18 years old 2. 1- to 3-vessel coronary artery disease (CAD) 3. Stable angina pectoris 4. At least 1 stenotic lesion suitable for PCI 5. No Q-wave myocardial infarction in the area undergoing CFI measurement 6. Written informed consent to participate in the study
Exclusion criteria
1. Acute myocardial infarction 2. Unstable CAD 3. CAD treated best by CABG 4. Patients with overt neoplastic disease 5. Patients with diabetic retinopathy 6. Liver or kidney disease 7. Pre-menopausal women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collateral flow index (CFI) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial blood flow (MBF) during hyperemia | 6 months |
Countries
Switzerland