Intra Coronary Autologous Stem Cell Transplantation in Acute Myocardial Infarction (AMI
- Registration Number
- CTRI/2010/091/000643
- Lead Sponsor
- Global Medical education & Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
Ages Eligible for Study: >21 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
?Acute ST elevation on MI.
?CPK-MB above 2 times; upper reference value.
?Recanalised culprit vessel
a)After successful PCI with stenting of culprit vessel.
b)Reanalyzed vessel after thrombolytic therapy with no residual lesion or residual lesion of <50%.
?Hypokinetic, Akinetic, Dyskinetic segment assessed by 2D-Echocardigraphy in standard 16-segment model.
?Multi vessel coronary artery disease (established).
?Previous MI with established significant Q-wave on ECG.
?Severe hepatic or renal dysfunction (Co-morbid Medical condition).
?Stroke with significant sequel.
?HIV/HBS/HCV positive serology.
?Short life expectancy due to cancer/ terminal illness which influence the patient.
?Mental disorder which interferes with possibility of Non-compliance with the protocol.
?Possibility of non-compliance with the protocol.
?Gross CCF/Pulmonary edema.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Improvement in LVEF perfusion measured by ECG, 2D-ECHO, Cardiac MRI, Coronary angiography.Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method ?Safety<br>?Improvement in myocardial function observed in SA node, AV node measured by ECG.<br>?Improved exercise time when observed on the 3rd and 6th month after the therapeutic procedure, when compare to exercise time before the administration of the therapeutic dose.<br>?Improvement in physical activity (Mild to Moderate), (Rest or Minimal to Mild).<br>?Reduction in the use of medicines. <br>Timepoint: 3 , 6 and 12 months