Filgrastim for the Promotion of Collateral Growth in Patients With CAD

This study has been completed.
Sponsor:
Collaborators:
Swiss National Science Foundation
Swiss Heart Foundation
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00596479
First received: January 8, 2008
Last updated: January 16, 2008
Last verified: January 2008
  Purpose

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 Intervention
Coronary Artery Disease
Drug: Filgrastim (rG-CSF)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Subcutaneous Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

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

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

Estimated Enrollment: 50
Study Start Date: November 2004
Study Completion Date: December 2007
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00596479     History of Changes
Other Study ID Numbers: 05/04
Study First Received: January 8, 2008
Last Updated: January 16, 2008
Health Authority: Switzerland: Swissmedic

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014