Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients

Study Overview
=================
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.

Official Title
-----------------
Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Biological: pegfilgrastim
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old 1- to 3-vessel coronary artery disease (CAD) Stable angina pectoris At least 1 stenotic lesion suitable for PCI No Q-wave myocardial infarction in the area undergoing CFI measurement Written informed consent to participate in the study Exclusion Criteria: Acute myocardial infarction Unstable CAD CAD treated best by CABG Patients with overt neoplastic disease Patients with diabetic retinopathy Liver or kidney disease Pre-menopausal women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collateral promotion; PCI after 6 months<br>First pegGCSF or placebo; PCI after 6 months | Biological: pegfilgrastim<br>* s.c. administration of pegylated G-CSF over 6 months<br>* Other names: pegylated (r-G-CSF);Other: Placebo<br>* Placebo control Arm 1: Collateral promotion; PCI after 6 months<br>* Other names: Placebo control;|
| Experimental: Collateral promotion after PCI at baseline<br>Collateral promotion with pegGCSF after PCI at baseline | Biological: pegfilgrastim<br>* s.c. administration of pegylated G-CSF over 6 months<br>* Other names: pegylated (r-G-CSF);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collateral flow index (CFI) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial blood flow (MBF) during hyperemia |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Stable, Coronary Collaterals, Therapeutic Collateral Promotion (TCP)