Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy

Ischemic Cardiopathy Clinical Trial

— THEANGIOGEN  

Official title:

Induced Angiogenesis by Genic Therapy With VEGF165 in Advanced Ischemic Cardiomyopathy - Historical Controlled Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00744315
• Other study ID #: UP3549
• Status: Unknown status
• Phase: Phase 2
• First received: August 27, 2008
• Last updated: October 14, 2008
• Start date: November 2007
• Est. completion date: May 2009

Study information

• Verified date: July 2008
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Imarilde Giusti, MD
• Phone: 555132192802
• Email: pesquisa[@]cardiologia.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: May 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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:

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiopathy

Intervention

Procedure:
• Mini-thoracotomy for intramyocardial injection of VEGF165
Patients with previous diagnosis of ischemic cardiopathy were included. The patient must accept and agree to be subject of clinical observation with current optimal treatment for at least 6 months. Following to that, subject undergoes intervention, in addition to consultation and assessments. Surgical technique -Ten injections VEGF165 will be made through a 25F butterfly needle in any ischemic territory where previously identified through scintigraphy. Dosis: 2.000 mg of VEGF165 in 5ml of saline solution. After the procedure, the patients will be kept in a recovery room for about 24hs and in the hospital until full clinical recovery.

Locations

Country	Name	City	State
Brazil	Institute of Cardiology of Rio Grande do Sul / FUC	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical finds		eighteen months