CClinicalTrials.gg
Sign In
CompletedNCT00596479Updated Jun 16, 2015

Filgrastim for the Promotion of Collateral Growth in Patients With CAD

An interventional study of Filgrastim (rG-CSF) in Coronary Artery Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-06-16.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • CAD
  • G-CSF
  • Collaterals
  • CFI
  • perfusion
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 50 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
50 participants (estimated)

Interventions

  • DrugFilgrastim (rG-CSF)
06

What researchers measure

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

07

Study locations

1 site
  • University Hospital Bern
    Bern, 3010, Switzerland
08

References and documents

Publications

  • 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. PubMed 19770393 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00596479
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation, Swiss Heart Foundation
Responsible party
Sponsor
First posted
Jan 17, 2008
Start date
Nov 2004
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Jun 16, 2015

Study contacts

Steffen Gloekler, MD
principal investigator · University of Bern
Tobias Rutz, MD
principal investigator · University of Bern
Pascal Meier, MD
principal investigator · University of Bern
Christian Seiler, MD
study chair · University of Bern
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Artery Disease→

Other studies from this sponsor

Insel Gruppe AG, University Hospital Bern

Start the discussion