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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Genetic: Stem Cell Transplantation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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.<br>* Other names: Stem Cell;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 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. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial, Infarction,, Stem, Cell, Therapy