Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00744315
First received: August 27, 2008
Last updated: October 14, 2008
Last verified: July 2008
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induced Angiogenesis by Genic Therapy With VEGF165 in Advanced Ischemic Cardiomyopathy - Historical Controlled Trial

Resource links provided by NLM:


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.

  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:

  • No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Study Director: Renato AK Kalil, MD, PhD Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC
  More Information

No publications provided by Instituto de Cardiologia do Rio Grande do Sul

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imarilde Giusti, Institute of Cardiology of Rio Grande do Sul/FUC
ClinicalTrials.gov Identifier: NCT00744315     History of Changes
Other Study ID Numbers: UP3549
Study First Received: August 27, 2008
Last Updated: October 14, 2008
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

Additional relevant MeSH terms:
Cardiomyopathies
Ischemia
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014