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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Genetic: Stem Cell Transplantation
Phase 2
Phase 3

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by National Heart Institute, Mexico:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725738

Contacts
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

Locations
Mexico
National Institute of Cardiology "Ignacio Chávez" Mexico Recruiting
Mexico, Distrito Federal, Mexico, 14080
Contact: Marco A Peña-Duque, MD    55732911 ext 1235-136    pernmar@cardiologia.org.mx   
Contact: Luis J Uribe-González, MD, MSc    55732911 ext 1235-1236    ljhonathanug@hotmail.com   
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         
Sponsors and Collaborators
National Heart Institute, Mexico
National Center of Blood Transfusion Mexico.
Investigators
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
  More Information

Publications:
Froelicher V, Myers J. Exercise and the heart. Fourth edition. Ed. Saunders. Philadelphia 2000. pp 456.

Responsible Party: Marco Antonio Peña Duque MD Interventional Cardiologist, National Institute of Cardiology "Ignacio Chávez"
ClinicalTrials.gov Identifier: NCT00725738     History of Changes
Other Study ID Numbers: 08-583
Study First Received: July 28, 2008
Last Updated: July 29, 2008
Health Authority: Mexico: Ethics Committee

Keywords provided by National Heart Institute, Mexico:
Myocardial
Infarction,
Stem
Cell
Therapy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014