Ischemic Cardiopathy
Conditions
Keywords
myocardial revascularization, myocardial ischemia, genetics, medical, Angiogenesis Inducing Agents
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.
Interventions
PROCEDUREMini-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.
Sponsors
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Instituto de Cardiologia do Rio Grande do Sul
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical finds | eighteen months |
Countries
Brazil
Contacts
Primary ContactImarilde Giusti, MD
Outcome results
None listed