Status:
UNKNOWN
Intracoronary Autologous Stem Cell Transplantation in ST Elevation Myocardial Infarction: TRACIA STUDY.
Lead Sponsor:
National Heart Institute, Mexico
Collaborating Sponsors:
National Center of Blood Transfusion Mexico.
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
PHASE3
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 transplantati...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00725738
Start Date
May 1 2008
End Date
December 1 2009
Last Update
July 30 2008
Active Locations (1)
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1
National Institute of Cardiology "Ignacio Chávez" Mexico
Mexico City, Mexico City, Mexico, 14080