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

July 29, 2008 updated by: National Heart Institute, Mexico

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Recruiting
        • National Institute of Cardiology "Ignacio Chávez" Mexico
        • Sub-Investigator:
          • Jorge Gaspar, MD
        • Contact:
        • Contact:
        • 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:
          • Eulo Lupi, MD
        • Sub-Investigator:
          • Sergio Férez-Santander, MD
        • Sub-Investigator:
          • Javier Figueroa, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Stem Cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Institute, Mexico

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

July 28, 2008

First Submitted That Met QC Criteria

July 29, 2008

First Posted (Estimate)

July 30, 2008

Study Record Updates

Last Update Posted (Estimate)

July 30, 2008

Last Update Submitted That Met QC Criteria

July 29, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-583

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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