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

October 14, 2008 updated by: Instituto de Cardiologia do Rio Grande do Sul

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90620001
        • Recruiting
        • Institute of Cardiology of Rio Grande do Sul / FUC
        • Contact:
        • Principal Investigator:
          • Imarilde Giusti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical finds
Time Frame: eighteen months
eighteen months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Study Director: Renato AK Kalil, MD, PhD, Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ANTICIPATED)

May 1, 2009

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (ESTIMATE)

August 29, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 15, 2008

Last Update Submitted That Met QC Criteria

October 14, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UP3549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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