Coronary Heart Disease Circulatory System Coronary Heart Disease
Conditions
Interventions
Status of trial amended to 'stopped' as of 05/04/2013 due to notification that it was not started.
The control group will receive a placebo stem cell transfusion made up of autologous heparinised pla
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 80 years 2. Acute myocardial infarction with chest pain, ST segment elevation >0.2 mV in more than two contiguous leads, peak Creatine Kinase (CK) >600 U/l, for MB isoenzyme 3. First documented Acute Myocardial Infarction (AMI) 4. Referred for rescue Percutaneous Coronary Intervention (PCI) 5. Thrombolysis In Myocardial Infarction (TIMI) grade three flow in infarct related artery following PCI 5. Ejection Fraction (EF) less than 45% following standard treatment 6. No plans for additional revascularisation during the course of the study
Exclusion criteria
Exclusion criteria: 1. TIMI grade zero or one flow despite intervention 2. Chronic inflammatory disease 3. Non-Infarct Related Artery (IRA) revascularisation likely over coming six months 4. Cerebral infarction within past year 5. More than 70% stenosis in non-IRA 6. Active infection (clinical/C-Reactive Protein (CRP)/White Blood Cells (WBC)/blood culture) 7. EF more than 45% following standard treatment 8. Known Human Immunodeficiency Virus (HIV) infection 9. Documented Previous Myocardial Infarction (MI) 10. Renal impairment (creatinine >180 mmol/l) 11. Previous Coronary Artery Bypass Graft (CABG)/PCI 12. Liver dysfunction (abnormal Liver Function Test or International Normalized Ratio (INR) >1.5) 13. Cardiogenic shock at presentation 14. Anaemia (haemaglobin less than 8.5 mg/dl) 15. History of neoplastic disease 16. Low platelet count (less than 100.000 µl) 17. History of hereditary bleeding disorder 18. History of gastro-intestinal bleeding within past three months 19. Major surgery/trauma within past two months 20. Women with childbearing potential 21. Arteriovenous Malformation (AVM)/aneurysms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in left ventricular function is determined by the comparison of the mean left ventricular EF in the stem cell treated and control groups, measured on initial MRI and that at four months in the early stem cell group and comparison of mean left ventricular EF measured at four months and one year in stem cell treated and control in the late treatment group. Maintenance of benefit will be assessed by comparison of EF at 12 months in subjects randomised to SCT in the early treatment group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All cause and cardiac mortality at 12 months 2. Troponin and CK enzyme rise at 12 months post all interventional procedures 3. Hospitalisation for heart failure (symptoms of dyspnoea at minimal effort or at rest despite conventional treatment) at twelve months 4. Recurrent MI within 12 months 5. Need for revascularisation (exercise tolerance test positive)(PCI/CABG) to Target Lesion Revascularisation (TLR) and non-TLR at four and 12 months 6. Hospitalisation for arrythmias 7. Presence of malignant arrythmias (ventricular fibrillation, ventricular tachycardia, frequent ventricular ectopics) on 24 hour Electro cardiogram (ECG) monitoring at one, six and 12 months 8. ANP/BNP measured at baseline, four and 12 months 9. Inflammatory status (full blood leucocytes count and C-Reactive Protein performed pre- and post- SCT) 10. Scar size assessed by Gadolinum enhanced MRI scans in 50% each group | — |
Countries
United Kingdom
Outcome results
None listed