Filgrastim for the Promotion of Collateral Growth in Patients With CAD
Subcutaneous Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Nov 2004
Typical duration for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2008
CompletedFirst Posted
Study publicly available on registry
January 17, 2008
CompletedJune 16, 2015
June 1, 2015
3.1 years
January 8, 2008
June 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
Secondary Outcomes (1)
Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 18 years old
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Insel Gruppe AG, University Hospital Bernlead
- Swiss National Science Foundationcollaborator
- Swiss Heart Foundationcollaborator
Study Sites (1)
University Hospital Bern
Bern, 3010, Switzerland
Related Publications (1)
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.
PMID: 19770393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steffen Gloekler, MD
University of Bern
- PRINCIPAL INVESTIGATOR
Tobias Rutz, MD
University of Bern
- PRINCIPAL INVESTIGATOR
Pascal Meier, MD
University of Bern
- STUDY CHAIR
Christian Seiler, MD
University of Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2008
First Posted
January 17, 2008
Study Start
November 1, 2004
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
June 16, 2015
Record last verified: 2015-06