Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy

Phase 2

• Conditions: Ischemic Cardiopathy
• Interventions: Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165

• Registration Number: NCT00744315
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

Human Vascular Endothelial Grown Factor 165 (hVEGF165) administration is promising therapy induces a new vessels, arterioles and capillaries in regions whose revascularization surgery is not possible by direct or by percutaneous angioplasty. This study aims to evaluate the clinical effects and safety of gene therapy with hVEGF165 in patients with advanced coronary artery disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Status Verified: 2008-07
• Primary Completion: 2008-07
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-29
• Last Update Submitted: 2008-10-14
• Last Update Posted: 2008-10-15
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Diagnosis coronary artery disease and symptomatic, despite optimal pharmacologic therapy
• Left ventricular dysfunction - left ventricular ejection fraction between 60% and 25% by echocardiogram
• Non-conventional revascularization, as seen by cineangiocardiography, attested by interventional cardiologist and cardiac surgeon
• Age below 75 years
• Absence of neoplasm

Exclusion Criteria

• No

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Mini-thoracotomy for intramyocardial injection of VEGF165	Controlled

Primary Outcome Measures

Name	Time	Method
Clinical finds	eighteen months

Trial Locations

Locations (1)

Institute of Cardiology of Rio Grande do Sul / FUC; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil