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

National Heart Institute, Mexico

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Genetic: Stem Cell Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00725738

08-583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 1 patient group

A

Experimental group

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.

Treatment:

Genetic: Stem Cell Transplantation