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Filgrastim for the Promotion of Collateral Growth in Patients With CAD

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Filgrastim (rG-CSF)
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CAD, G-CSF, Collaterals, CFI, perfusion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Bern

Outcomes

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

Full Information

First Posted
January 8, 2008
Last Updated
June 15, 2015
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation, Swiss Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00596479
Brief Title
Filgrastim for the Promotion of Collateral Growth in Patients With CAD
Official Title
Subcutaneous Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Swiss National Science Foundation, Swiss Heart Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, G-CSF, Collaterals, CFI, perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Filgrastim (rG-CSF)
Primary Outcome Measure Information:
Title
Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
Secondary Outcome Measure Information:
Title
Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Gloekler, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tobias Rutz, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pascal Meier, MD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Seiler, MD
Organizational Affiliation
University of Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19770393
Citation
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.
Results Reference
derived

Learn more about this trial

Filgrastim for the Promotion of Collateral Growth in Patients With CAD

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