Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy (THEANGIOGEN)

Instituto de Cardiologia do Rio Grande do Sul

Status and phase: Unknown; Phase 2

Conditions: Ischemic Cardiopathy

Treatments: Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165

Study type: Interventional

Funder types: Other

Identifiers

NCT00744315

UP3549

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Other group

Description:

Controlled

Treatment:

Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165