Filgrastim for the Promotion of Collateral Growth in Patients With CAD
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00596479
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.
- Detailed Description
The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
- Patients admitted as emergencies
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
- Secondary Outcome Measures
Name Time Method Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up
Trial Locations
- Locations (1)
University Hospital Bern
🇨🇭Bern, Switzerland