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Filgrastim for the Promotion of Collateral Growth in Patients With CAD

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ClinicalTrials.gov Identifier: NCT00596479
Recruitment Status : Completed
First Posted : January 17, 2008
Last Update Posted : June 16, 2015
Sponsor:
Collaborators:
Swiss National Science Foundation
Swiss Heart Foundation
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Filgrastim (rG-CSF) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Subcutaneous Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study Start Date : November 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI

Secondary Outcome Measures :
  1. Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596479


Locations
Switzerland
University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Swiss National Science Foundation
Swiss Heart Foundation
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00596479     History of Changes
Other Study ID Numbers: 05/04
First Posted: January 17, 2008    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

Keywords provided by University Hospital Inselspital, Berne:
CAD
G-CSF
Collaterals
CFI
perfusion

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs