Status:
COMPLETED
Angiogenesis Using VEGF-A165/bFGF Plasmid Delivered Percutaneously in No-option CAD Patients; a Controlled Trial
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Collaborating Sponsors:
Center of Oncology, Warsaw, Poland
Medical University of Warsaw
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Achieving therapeutic angiogenesis with gene therapy using a plasmid coding human VEGF-A165/bFGF injected into ischemic myocardium of refractory coronary artery disease patients, employing a percutane...
Detailed Description
Aim of the Study: Achieving therapeutic angiogenesis with gene therapy using a plasmid coding human VEGF-A165/bFGF injected into ischemic myocardium of refractory coronary artery disease patients, em...
Eligibility Criteria
Inclusion
- Severe (\>= CCS III) ischemic heart disease despite optimal medical treatment in patients not amenable to percutaneous transluminal coronary angioplasty or coronary artery bypass surgery
- Left ventricular ejection fraction \>35%
- Significant stress-induced reversible ischemic area documented on dipyridamole stress myocardial perfusion scintigraphy
- Able to understand and willing to sign the informed consent
- Older than 18 years of age
Exclusion
- Angina \<CCS III
- Secondary angina
- Acute myocardial infarction within 4 weeks prior to inclusion
- Diabetes with proliferative retinopathy
- Diagnosed or suspected tumor
- Chronic inflammatory or autoimmune disease
- Fertile women
- Left ventricular ejection fraction \<35%
- Patients not willing to or not able to give the informed consent to participate in the study
- Patients with a severe disease (other than CAD) having life-expectancy below 1 year
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00620217
Start Date
December 1 2004
End Date
May 1 2009
Last Update
December 1 2009
Active Locations (1)
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1
Institute of Cardiology
Warsaw, Poland, 04-628