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

Primary Purpose

Ischemic Cardiopathy

Status

Unknown status

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Mini-thoracotomy for intramyocardial injection of VEGF165

About this trial

This is an interventional treatment trial for Ischemic Cardiopathy focused on measuring myocardial revascularization, myocardial ischemia, genetics, medical, Angiogenesis Inducing Agents

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

Institute of Cardiology of Rio Grande do Sul / FUCRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Controlled

Outcomes

Primary Outcome Measures

Clinical finds

Secondary Outcome Measures

Full Information

NCT ID

NCT00744315

First Posted

August 27, 2008

Last Updated

October 14, 2008

Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Collaborators

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT00744315

Brief Title

Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy

Acronym

THEANGIOGEN

Official Title

Induced Angiogenesis by Genic Therapy With VEGF165 in Advanced Ischemic Cardiomyopathy - Historical Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Unknown status

Study Start Date

November 2007 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Instituto de Cardiologia do Rio Grande do Sul

Collaborators

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Cardiopathy

Keywords

myocardial revascularization, myocardial ischemia, genetics, medical, Angiogenesis Inducing Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Controlled

Intervention Type

Procedure

Intervention Name(s)

Mini-thoracotomy for intramyocardial injection of VEGF165

Intervention Description

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.

Primary Outcome Measure Information:

Title

Clinical finds

Time Frame

eighteen months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Imarilde Giusti, MD

Phone

555132192802

Ext

pesquisa@cardiologia.org.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renato AK Kalil, MD, PhD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

Institute of Cardiology of Rio Grande do Sul / FUC

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90620001

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Imarilde Giusti, MD

Phone

555132303600

Ext

3652

kalil.pesquisa@cardiologia.org.br

First Name & Middle Initial & Last Name & Degree

Imarilde Giusti, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23944648

Citation

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.

Results Reference

derived

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Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy

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