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

National Heart Institute, Mexico80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

Stem Cell TransplantationGENETIC

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Institute of Cardiology "Ignacio Chávez" Mexico

Mexico City, Mexico City, Mexico

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

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

Central Contacts

Marco A Peña-Duque, MD

CONTACT

55732911 penmar@cardiologia.org.mx

Luis J Uribe-González, MD, MSc

CONTACT

55732911 ljhonathanug@hotmail.com

Data from ClinicalTrials.gov

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