Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy
NCT ID: NCT00744315
Last Updated: 2008-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2007-11-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Controlled
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
75 Years
ALL
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Instituto de Cardiologia do Rio Grande do Sul
OTHER
Responsible Party
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Institute of Cardiology of Rio Grande do Sul/FUC
Principal Investigators
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Renato AK Kalil, MD, PhD
Role: STUDY_DIRECTOR
Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC
Locations
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Institute of Cardiology of Rio Grande do Sul / FUC
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Imarilde Giusti, MD
Role: primary
References
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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.
Other Identifiers
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UP3549
Identifier Type: -
Identifier Source: org_study_id