Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy - Full Text View

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

This study is currently recruiting participants.

Verified by Instituto de Cardiologia do Rio Grande do Sul, July 2008

Sponsors and Collaborators:	Instituto de Cardiologia do Rio Grande do Sul FAPERGS CNPq
Information provided by:	Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:	NCT00744315

Purpose

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.

Condition	Intervention	Phase
Ischemic Cardiopathy	Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165	Phase II

MedlinePlus related topics: Cardiomyopathy Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Induced Angiogenesis by Genic Therapy With VEGF165 in Advanced Ischemic Cardiomyopathy - Historical Controlled Trial

Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:

Clinical finds [ Time Frame: eighteen months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Controlled	Procedure: 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.

Arms

Assigned Interventions

Controlled

Procedure: 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

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744315

Contacts

Contact: Imarilde Giusti, MD

555132192802 ext 23

pesquisa@cardiologia.org.br

Locations

Brazil, Rio Grande do Sul
Institute of Cardiology of Rio Grande do Sul / FUC	Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90620001
Contact: Imarilde Giusti, MD 555132303600 ext 3652 kalil.pesquisa@cardiologia.org.br
Principal Investigator: Imarilde Giusti, MD

Sponsors and Collaborators

Instituto de Cardiologia do Rio Grande do Sul

FAPERGS

CNPq

Investigators

Study Director:

Renato AK Kalil, MD, PhD

Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC

More Information

Responsible Party:	Institute of Cardiology of Rio Grande do Sul/FUC ( Imarilde Giusti )
Study ID Numbers:	UP3549
Study First Received:	August 27, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00744315
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:

myocardial revascularization
myocardial ischemia
genetics, medical
Angiogenesis Inducing Agents

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Ischemia
Cardiomyopathies

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009