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Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
pegfilgrastim
Placebo
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Stable, Coronary Collaterals, Therapeutic Collateral Promotion (TCP)

Eligibility Criteria

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

Inclusion Criteria:

  1. Age > 18 years old
  2. 1- to 3-vessel coronary artery disease (CAD)
  3. Stable angina pectoris
  4. At least 1 stenotic lesion suitable for PCI
  5. No Q-wave myocardial infarction in the area undergoing CFI measurement
  6. Written informed consent to participate in the study

Exclusion Criteria:

  1. Acute myocardial infarction
  2. Unstable CAD
  3. CAD treated best by CABG
  4. Patients with overt neoplastic disease
  5. Patients with diabetic retinopathy
  6. Liver or kidney disease
  7. Pre-menopausal women

Sites / Locations

  • University Hospital Berne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Collateral promotion; PCI after 6 months

Collateral promotion after PCI at baseline

Arm Description

First pegGCSF or placebo; PCI after 6 months

Collateral promotion with pegGCSF after PCI at baseline

Outcomes

Primary Outcome Measures

Collateral flow index (CFI)

Secondary Outcome Measures

Myocardial blood flow (MBF) during hyperemia

Full Information

First Posted
April 22, 2009
Last Updated
December 15, 2015
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT00886509
Brief Title
Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients
Official Title
Subcutaneous Administration of Pegylated Granulocyte-Colony Stimulating Factor for Long-Term Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study in patients with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the long-term efficacy and safety of subcutaneously applied, pegylated granulocyte colony stimulating factor (Pegfilgrastim, PEG-G-CSF; Neulasta®, Amgen Switzerland) with regard to the promotion of collateral growth.
Detailed Description
Coronary artery disease (CAD) is the leading cause of death in industrialized countries. Current revascularization therapies are PCI or surgical revascularization. However, inherent to them are procedure-related risks and the fact, that progression of CAD is not prevented. Additionally, up to one fourth of all CAD patients are not amenable to standard revascularization therapies. Thus, there is a need for alternative therapies. The coronary collateral circulation is prevalent in humans, and in CAD the amount of collateral flow is a pivotal protective factor with respect to infarct size, all-cause- and cardiac mortality. Coronary collateral growth promotion is an alternative to conventional revascularization which can be achieved by cytokine-based approaches (e.g. with colony-stimulating factor-therapy) in humans. The goal of collateral promotion is to reduce myocardial damage in case of a coronary occlusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Stable, Coronary Collaterals, Therapeutic Collateral Promotion (TCP)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collateral promotion; PCI after 6 months
Arm Type
Experimental
Arm Description
First pegGCSF or placebo; PCI after 6 months
Arm Title
Collateral promotion after PCI at baseline
Arm Type
Experimental
Arm Description
Collateral promotion with pegGCSF after PCI at baseline
Intervention Type
Biological
Intervention Name(s)
pegfilgrastim
Other Intervention Name(s)
Peg-GCSF, Peg-G-CSF, PEG-rmetHuG-CSF, Amgen brand of pegfilgrastim, Neulasta, pegylated (r-G-CSF)
Intervention Description
s.c. administration of pegylated G-CSF over 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo control
Intervention Description
Placebo control Arm 1: Collateral promotion; PCI after 6 months
Primary Outcome Measure Information:
Title
Collateral flow index (CFI)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Myocardial blood flow (MBF) during hyperemia
Time Frame
6 months

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: 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
Christian Seiler, MD, Prof.
Organizational Affiliation
University of Bern
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tobias Traupe, MD
Organizational Affiliation
University Hospital Berne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Stoller, MD
Organizational Affiliation
University Hospital Berne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Berne
City
Berne
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
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Peg-Granulocyte-Colony Stimulating Factor (GCSF) for Coronary Collateral Growth in Coronary Artery Disease Patients

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