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Status unknownNCT00744315THEANGIOGENUpdated Oct 15, 2008

Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy

A Phase 2 interventional study of Mini-thoracotomy for intramyocardial injection of VEGF165 in Ischemic Cardiopathy, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Status unknown at 1 site in Brazil. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2008-10-15.

Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
Up to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Cardiopathy

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Keywords

  • myocardial revascularization
  • myocardial ischemia
  • genetics, medical
  • Angiogenesis Inducing Agents
03

In context

Myocardial Ischemia

3,242 studies on the registry are indexed under Myocardial Ischemia; 390 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 1,901 interventional studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 76 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • No
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    1

    Controlled

    Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165

Interventions

  • ProcedureMini-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.

06

What researchers measure

Primary outcomes

  1. Clinical finds

    Time frame: eighteen months

07

Study locations

1 of 1 sites recruiting
  • Institute of Cardiology of Rio Grande do Sul / FUC
    Porto Alegre, Rio Grande do Sul 90620001, Brazil
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23944648 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2007, a primary completion of Jul 2008 and a completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2008
First posted
Aug 29, 2008
Start
Nov 2007
Primary completionActual
Jul 2008
CompletionEst.
May 2009
Last update
Oct 15, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00744315
Lead 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
First posted
Aug 29, 2008
Start date
Nov 2007
Primary completion
Jul 2008
Completion
May 2009 (estimated)
Last update
Oct 15, 2008

Study contacts

Imarilde Giusti, MD
Contact
pesquisa@cardiologia.org.br
555132192802 ext. 23
Renato AK Kalil, MD, PhD
study director · Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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