Trials / Unknown
UnknownNCT00725738
Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY.
Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA Study.
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- National Heart Institute, Mexico · Other Government
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the ejection fraction (EF) increase at 6 months follow up and major adverse cardiovascular events (MACE) after intracoronary autologous stem cell transplantation in ST elevation myocardial infarction patients versus a control group.
Detailed description
Experimental trials with bone marrow cell have suggested that adult stem cell can contribute to regeneration of infarcted myocardial muscle and increase the neovascularization of the ischemic tissue. Post-myocardial infarction heart failure secondary to ventricular remodelation it's an increasing problem. A novel therapeutic approach for decrease this consequence is to induce the angiogeneses and regeneration of myocardial cells. Many trials have shown benefits through the intracoronary injection of stem cell, however the clinical benefit is still controversial. The present trial is a randomized single blinded controlled trial designed to evaluate the improvement on EF and survival in post ST elevation myocardial infarction patients undergoing to intracoronary autologous stem cell transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Stem Cell Transplantation | 1-2 million of CD34 cells injected through the infarct related artery by PTCA "over-the-wire" catheter during multiple sequences of balloon artery occlusion with a mean duration of 30 minutes. |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2008-07-30
- Last updated
- 2008-07-30
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT00725738. Inclusion in this directory is not an endorsement.