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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Controlled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini-thoracotomy for intramyocardial injection of VEGF165 | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical finds | eighteen months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imarilde Giusti, MD | Contact | 555132192802 | 23 | pesquisa@cardiologia.org.br |
| Name | Affiliation | Role |
|---|---|---|
| Renato AK Kalil, MD, PhD | Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology of Rio Grande do Sul / FUC | Recruiting | Porto Alegre | Rio Grande do Sul | 90620001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23944648 | Derived | Giusti II, Rodrigues CG, Salles FB, Sant'Anna RT, Eibel B, Han SW, Ludwig E, Grossman G, Prates PR, Sant'Anna JR, Filho GF, Markoski MM, Nesralla IA, Nardi NB, Kalil RA. High doses of vascular endothelial growth factor 165 safely, but transiently, improve myocardial perfusion in no-option ischemic disease. Hum Gene Ther Methods. 2013 Oct;24(5):298-306. doi: 10.1089/hgtb.2012.221. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 21, 2011 | |
| Unrelease | Yes | |
| Release | Dec 7, 2011 | |
| Reset | Jan 11, 2012 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 21, 2011 | Yes | |||
| Dec 7, 2011 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Jan 11, 2012 |