Filgrastim for the Promotion of Collateral Growth in Patients With CAD

Insel Gruppe AG, University Hospital Bern50 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Filgrastim (rG-CSF)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Bern

Bern, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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