Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by National Heart Institute, Mexico.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Center of Blood Transfusion Mexico.
Information provided by:
National Heart Institute, Mexico
ClinicalTrials.gov Identifier:
NCT00725738
First received: July 28, 2008
Last updated: July 29, 2008
Last verified: July 2008

July 28, 2008
July 29, 2008
May 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00725738 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY.
Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA Study.

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
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: A
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.
Intervention: Genetic: Stem Cell Transplantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Both gender patients between 20 and 75 years old with an acute myocardial infarction (less 24 hrs of symptoms) undergoing to primary angioplasty.
  • LVEF < o = 45% by MRI, radioisotopic ventriculography or echocardiogram.
  • Informed written consent.

Exclusion Criteria:

  • Cardiogenic Shock.
  • Post-myocardial infarction mechanical complication
  • Malignant ventricular arrythmias
  • History of malignant disease during the last five years.
  • Pregnancy
  • Renal chronic disease with a creatinine level > 2.6 mg/dl.
  • Any kind of stroke during the last year.
  • Any chronic disease that can affect the patient survival during the trial.
Both
20 Years to 75 Years
No
Contact: Marco A Peña-Duque, MD 55732911 ext 1235-1236 penmar@cardiologia.org.mx
Contact: Luis J Uribe-González, MD, MSc 55732911 ext 1235-1236 ljhonathanug@hotmail.com
Mexico
 
NCT00725738
08-583
No
Marco Antonio Peña Duque MD Interventional Cardiologist, National Institute of Cardiology "Ignacio Chávez"
National Heart Institute, Mexico
National Center of Blood Transfusion Mexico.
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
National Heart Institute, Mexico
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP