Ischemic CardiopathyPhase 2THEANGIOGENNCT00744315
Induced Angiogenesis by Genic Therapy in Advanced Ischemic Cardiomyopathy
A Phase 2 study testing Mini-thoracotomy for intramyocardial injection of VEGF165 in people with Ischemic Cardiopathy, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Ischemic Cardiopathy
- What is being tested?
- Mini-thoracotomy for intramyocardial injection of VEGF165
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2007to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Institute of Cardiology of Rio Grande do Sul / FUC
Porto Alegre, Rio Grande do Sul, 90620001
Imarilde Giusti, MD, 555132303600 ext. 3652, kalil.pesquisa@cardiologia.org.br
Imarilde Giusti, MD
About this study
Official title: 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.
- Conditions
- Ischemic Cardiopathy
- Being tested
- Mini-thoracotomy for intramyocardial injection of VEGF165
- Keywords
- myocardial revascularization, myocardial ischemia, genetics, medical, Angiogenesis Inducing Agents
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-thoracotomy for intramyocardial injection of VEGF165Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Controlled Receives: Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical finds
Measured: eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic CardiopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Investigators
- Renato AK Kalil, MD, PhD, Study director, Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744315
- Sponsor's protocol ID
- UP3549
- Acronym
- THEANGIOGEN
- Status last verified
- Jul 2008
- First submitted
- 27 Aug 2008
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Angiogenesis by Genic Therapy With VEGF165 in Advanced Ischemic Cardiomyopathy - Historical Controlled Trial
- ClinicalTrials.gov ID
- NCT00744315
- Acronym / sponsor ID
- THEANGIOGEN / UP3549
- Conditions
- Ischemic Cardiopathy
- Keywords
- myocardial revascularization, myocardial ischemia, genetics, medical, Angiogenesis Inducing Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- May 2009 (estimated)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Mini-thoracotomy for intramyocardial injection of VEGF165Controlled |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-thoracotomy for intramyocardial injection of VEGF165Patients 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. | Procedure or surgery | 1 |
Primary outcome
Clinical finds
Time frame: eighteen months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2008.
- Derived from this study: PubMed 23944648Giusti 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato AK Kalil, MD, PhD study director
Scientific Direction - Institute of Cardiology of Rio Grande do Sul / FUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mini-thoracotomy for intramyocardial injection of VEGF165 in people with Ischemic Cardiopathy, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imarilde Giusti, MD (555132192802 ext. 23, pesquisa@cardiologia.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical finds (time frame: eighteen months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2008.