Health Condition 1: null- Recent MI and occluded infarct related arteries supplying a large myocardial territory
Conditions
Interventions
Intervention1: Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting: autologous bone marrow stem cells from iliac crest 60 ml bon
Sponsors
Indian Council Of Medical Research New Delhi India
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Recent MI (3-28 d) 2. Obstructed artery needing intervention 3. consent for stem cell therapy Exclusion criteria 1. Left main disease or TVD needing surgery 2. Hypotension 3. Consent not given
Exclusion criteria
Exclusion criteria: . Patients with significant proximal 3-vessel or left main disease are excluded regardless of functional test results. 2. Patients with post-MI rest angina are not eligible 3. Age <18 yrs 4. Clinical indication for revascularization 5. Serious illness such as cancer or pulmonary disease that limits 3-year survival 6. Severe renal disease defined as serum creatinine &#8805;3.0 mg/dL that markedly increases risk of radiographic contrast 7. Severe valvular disease 8. History of anaphylaxis to radiographic contrast 9. Infarct artery too small (reference segment diameter <2.5 mm), target segment within or beyond extreme tortuosity (>90º angulation), or otherwise technically a poor candidate for PCI 10 Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographic evidence of chronicity, eg, presence of bridging collaterals) 11. NYHA classes III-IV CHF; patients may be treated for acute heart failure complicating MI and rescreened 12. Cardiogenic shock or sustained hypotension: systolic BP &#8804;90 mm Hg or cardiac index &#8804;2.2 L/min per m2 13. LV aneurysm in the same location as index MI and present before index MI 14. Inability to cooperate with the protocol 15. Patient refusal or inability to give informed consent 16. Refusal of patient?s physician to allow patient to participate 17. Pregnancy 18. Contraindication to anticoagulation during PCI or to routine antiplatelet therapy after stent implantation 19. Qualifying IRA that has been grafted previously; patients with prior CABG may be enrolled if the IRA was not previously grafted. Dilated or hypertrophic cardiomyopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in left ventricular function (assessed by Nuclear imaging and ECHO) and change in myocardial viability [assessed by PET].Timepoint: 3 months for imaging studies. One year clinical events. | — |
Secondary
| Measure | Time frame |
|---|---|
| change in functional capacity as assessed by 6 minute walk test, quality of life assessment, first occurrence of recurrent MI,Timepoint: 3months and 12 months | — |
Countries
India
Contacts
Public ContactDr Sujata Mohanty
AIIMS
Outcome results
None listed