Cardiac disease/ coronary surgery Circulatory System Acute myocardial infarction
Conditions
Interventions
Experimental intervention: Injection of enriched autologous CD133+ stem cells derived from bone marrow, suspended in autologous plasma
Comparator intervention: Injection of autologous plasma
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Sponsors
United Bristol Healthcare NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of either sex, aged 16 years or over and under 80 years 2. Recent (>10 days and 3 months) anterior ST-Segment Elevation Myocardial Infarction (STEMI) who have not undergone primary angioplasty 3. Cardiac magnetic resonance imaging (MRI) documented anterior myocardial infarction (MI) with a transmurality of >= 50% wall thickness in at least 1 segment of the LAD territory 4. Requirement for coronary artery bypass graft (CABG) alone to bypass stenoses or occlusions of the left anterior descending artery (LAD) territory and any other territory as dictated by baseline coronary angiography 5. Absence of LV dilation (LV end systolic volume index <60 ml/m^2)
Exclusion criteria
Exclusion criteria: 1. Presence of cardiogenic shock or presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema 2. Cardiac MRI documented MI transmurality of 60 ml/m^2) 4. Cardiomyopathy secondary to a reversible cause 5. Known active infection 6. Chronic inflammatory disease 7. Serum creatinine >= 200 mmol/L 8. Contraindications for bone marrow aspiration 9. Female subjects of childbearing potential 10. Emergency operation for unstable angina 11. History of pace-maker or defibrillator insertion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regional LV thickening of the injected segments of the left ventricle 6 months after surgery measured by cardiac MRI. The use of MRI will also allow us to ascertain the reasons for any observed changes in wall thickening at the injected sites at 6 months by comparing the transmural distribution of viable myocardium and scar before and after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following outcomes will be measured pre-operatively and at 6 months after surgery: 1. Scar distribution and the viability of the myocardium with MRI 2. LV segmental and global function with echocardiography 3. Mid-term generic and cardiac specific health status and quality of life. These will be assessed by the disease-specific Coronary Revascularisation Outcome Questionnaire, the Minnesota Living with Heart Failure Questionnaire and the 36-item Short Form health survey (SF-36) 4. Myocardial injury throughout the entire study period by measuring troponin I levels | — |
Countries
United Kingdom
Outcome results
None listed