Clinical trial NCT00725738: Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY.
Official title: Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Acute Myocardial Infarction
Keywords: Myocardial
Infarction,
Stem
Cell
Therapy
Lead sponsor: National Heart Institute, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: National Center of Blood Transfusion Mexico.
First posted: 2008-07-30
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: National Institute of Cardiology "Ignacio Chávez" Mexico
state: Distrito Federal
Study officials:
affiliation: National Institute of Cardiology "Ignacio Chávez" Mexico
name: Marco A Peña-Duque, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology "Ignacio Chávez" Mexico
name: Marco A Peña-Duque, MD
role: STUDY_DIRECTOR
affiliation: National Institute of Cardiology "Ignacio Chávez" Mexico
name: Marco A Peña-Duque, MD
role: STUDY_CHAIR
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