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

Primary Purpose

Acute Myocardial Infarction

Status

Unknown status

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Stem Cell Transplantation

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Myocardial, Infarction,, Stem, Cell, Therapy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institute of Cardiology "Ignacio Chávez" MexicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

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.

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.

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.

Full Information

NCT ID

NCT00725738

First Posted

July 28, 2008

Last Updated

July 29, 2008

Sponsor

National Heart Institute, Mexico

Collaborators

National Center of Blood Transfusion Mexico.

1. Study Identification

Unique Protocol Identification Number

NCT00725738

Brief Title

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

Acronym

TRACIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Unknown status

Study Start Date

May 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Heart Institute, Mexico

Collaborators

National Center of Blood Transfusion Mexico.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

Keywords

Myocardial, Infarction,, Stem, Cell, Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Genetic

Intervention Name(s)

Stem Cell Transplantation

Other Intervention Name(s)

Stem Cell

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

6 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marco A Peña-Duque, MD

Phone

55732911

Ext

1235-1236

penmar@cardiologia.org.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Luis J Uribe-González, MD, MSc

Phone

55732911

Ext

1235-1236

ljhonathanug@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marco A Peña-Duque, MD

Organizational Affiliation

National Institute of Cardiology "Ignacio Chávez" Mexico

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marco A Peña-Duque, MD

Organizational Affiliation

National Institute of Cardiology "Ignacio Chávez" Mexico

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Marco A Peña-Duque, MD

Organizational Affiliation

National Institute of Cardiology "Ignacio Chávez" Mexico

Official's Role

Study Chair

Facility Information:

Facility Name

National Institute of Cardiology "Ignacio Chávez" Mexico

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

14080

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marco A Peña-Duque, MD

Phone

55732911

Ext

1235-136

pernmar@cardiologia.org.mx

First Name & Middle Initial & Last Name & Degree

Luis J Uribe-González, MD, MSc

Phone

55732911

Ext

1235-1236

ljhonathanug@hotmail.com

First Name & Middle Initial & Last Name & Degree

Fause Attie, MD

First Name & Middle Initial & Last Name & Degree

Rafael A Marin-López, MD

First Name & Middle Initial & Last Name & Degree

Marco A Martínez-Ríos, MD

First Name & Middle Initial & Last Name & Degree

Eva Calderón-Garcidueñas, MSc, PhD

First Name & Middle Initial & Last Name & Degree

Luis J Uribe-González, Md, MSc

First Name & Middle Initial & Last Name & Degree

Ana M Mejia, MD

First Name & Middle Initial & Last Name & Degree

Felipe Masso, MD, MSc

First Name & Middle Initial & Last Name & Degree

Carlos Martínez-Sánchez, MD

First Name & Middle Initial & Last Name & Degree

Héctor González-Pacheco, MD

First Name & Middle Initial & Last Name & Degree

David Bialostozky, MD

First Name & Middle Initial & Last Name & Degree

Erick Alexanderson, MD

First Name & Middle Initial & Last Name & Degree

Aloha Meave, MD

First Name & Middle Initial & Last Name & Degree

Ilarraza Hermes, MD, MSc

First Name & Middle Initial & Last Name & Degree

Ramón Villavicencio, MD

First Name & Middle Initial & Last Name & Degree

Enrique Gómez, MD, MSc

First Name & Middle Initial & Last Name & Degree

Jorge Gaspar, MD

First Name & Middle Initial & Last Name & Degree

Eulo Lupi, MD

First Name & Middle Initial & Last Name & Degree

Sergio Férez-Santander, MD

First Name & Middle Initial & Last Name & Degree

Javier Figueroa, MD, MSc

12. IPD Sharing Statement

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

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