Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY.
Recruitment status was Recruiting
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.
Acute Myocardial Infarction
Genetic: Stem Cell Transplantation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA Study.|
- Evaluate the mean LVEF increase by magnetic resonance imaging (MRI) at 6 months of follow up between the stem cell group and the control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Evaluate the left ventricular end diastolic volume (LVEDV) and left ventricular end systolic volume (LVESV)with image magnetic resonance(IMR) at 6 months follow up between stem cell and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Evaluate the oxygen consumption during treadmill stress test (MVO2) by expired gases analysis and the incidence of MACE at 6 months follow up between stem cell and control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Stem Cell Transplantation Group: Between the fifth and seventh day post-primary angioplasty (PTCA) we extract the stem cell from iliac crest and during the same day the patient undergoes to a new cardiac catheterization in which we perform the intracoronary injection (about 1-2 million of CD34 cells) through the infarct related artery by a PTCA "over-the-wire" catheter.
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.
Other Name: Stem Cell
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725738
|Contact: Marco A Peña-Duque, MD||55732911 ext email@example.com|
|Contact: Luis J Uribe-González, MD, MSc||55732911 ext firstname.lastname@example.org|
|National Institute of Cardiology "Ignacio Chávez" Mexico||Recruiting|
|Mexico, Distrito Federal, Mexico, 14080|
|Contact: Marco A Peña-Duque, MD 55732911 ext 1235-136 email@example.com|
|Contact: Luis J Uribe-González, MD, MSc 55732911 ext 1235-1236 firstname.lastname@example.org|
|Sub-Investigator: Fause Attie, MD|
|Sub-Investigator: Rafael A Marin-López, MD|
|Sub-Investigator: Marco A Martínez-Ríos, MD|
|Sub-Investigator: Eva Calderón-Garcidueñas, MSc, PhD|
|Sub-Investigator: Luis J Uribe-González, Md, MSc|
|Sub-Investigator: Ana M Mejia, MD|
|Sub-Investigator: Felipe Masso, MD, MSc|
|Sub-Investigator: Carlos Martínez-Sánchez, MD|
|Sub-Investigator: Héctor González-Pacheco, MD|
|Sub-Investigator: David Bialostozky, MD|
|Sub-Investigator: Erick Alexanderson, MD|
|Sub-Investigator: Aloha Meave, MD|
|Sub-Investigator: Ilarraza Hermes, MD, MSc|
|Sub-Investigator: Ramón Villavicencio, MD|
|Sub-Investigator: Enrique Gómez, MD, MSc|
|Sub-Investigator: Jorge Gaspar, MD|
|Sub-Investigator: Eulo Lupi, MD|
|Sub-Investigator: Sergio Férez-Santander, MD|
|Sub-Investigator: Javier Figueroa, MD, MSc|
|Principal Investigator:||Marco A Peña-Duque, MD||National Institute of Cardiology "Ignacio Chávez" Mexico|
|Study Director:||Marco A Peña-Duque, MD||National Institute of Cardiology "Ignacio Chávez" Mexico|
|Study Chair:||Marco A Peña-Duque, MD||National Institute of Cardiology "Ignacio Chávez" Mexico|