## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 05/04
#### Organization
**Class:** OTHER
**Full Name:** Insel Gruppe AG, University Hospital Bern
### Status Module
#### Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-06-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-12

**Type:** ACTUAL

#### Start Date
**Date:** 2004-11

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2008-01-17
**Type:** ESTIMATED
**Study First Submit Date:** 2008-01-08
**Study First Submit QC Date:** 2008-01-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Swiss National Science Foundation

**Class:** OTHER

**Name:** Swiss Heart Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Insel Gruppe AG, University Hospital Bern

#### Responsible Party

**Type:** SPONSOR

### Description Module

**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.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- CAD

- G-CSF

- Collaterals

- CFI

- perfusion

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Filgrastim (rG-CSF)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI

#### Secondary Outcomes

**Measure:** Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up

### Eligibility Module

**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

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bern

**Country:** Switzerland

**Facility:** University Hospital Bern

**Zip:** 3010

#### Overall Officials

**Official 1:**

**Affiliation:** University of Bern

**Name:** Steffen Gloekler, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Bern

**Name:** Tobias Rutz, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** University of Bern

**Name:** Pascal Meier, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** University of Bern

**Name:** Christian Seiler, MD

**Role:** STUDY_CHAIR

### References Module

#### References

**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.

**PMID:** 19770393

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

### Intervention Browse Module - Ancestors

- ID: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1945

- Name: Lenograstim

- Relevance: HIGH

- As Found: 30 minutes

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000078224

- Term: Lenograstim

### Misc Info Module

- Version Holder: 2024-05-24
