Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy
THEANGIOGEN
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 27, 2008
CompletedFirst Posted
Study publicly available on registry
August 29, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedOctober 15, 2008
July 1, 2008
8 months
August 27, 2008
October 14, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical finds
eighteen months
Study Arms (1)
1
OTHERControlled
Interventions
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Cardiology of Rio Grande do Sul / FUC
Porto Alegre, Rio Grande do Sul, 90620001, Brazil
Related Publications (1)
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.
PMID: 23944648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Renato AK Kalil, MD, PhD
Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 27, 2008
First Posted
August 29, 2008
Study Start
November 1, 2007
Primary Completion
July 1, 2008
Study Completion
May 1, 2009
Last Updated
October 15, 2008
Record last verified: 2008-07