Clinical trial NCT00886509: Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients
Official title: Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Stable
Coronary Collaterals
Therapeutic Collateral Promotion (TCP)
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Collateral flow index (CFI)
timeFrame: 6 months
Secondary outcomes:
measure: Myocardial blood flow (MBF) during hyperemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: University Hospital Berne
Study officials:
affiliation: University of Bern
name: Christian Seiler, MD, Prof.
role: STUDY_CHAIR
affiliation: University Hospital Berne
name: Tobias Traupe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Berne
name: Michael Stoller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.