Percutaneous Randomised Infusion of Marrow Aspirate To Improve Ventricular Efficiency

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: 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 plasma and the study group will receive autologous Stem Cell Therapy (SCT). The following measurements will be made: 1. Coronary Angiogram 2. Four Magnetic Resonance Imaging (MRI) scans 3. Bone marrow cell aspiration 4. Stem cell transfusion 5. Holter monitoring 6. Atrial Natriuretic Peptide (ANP)/Brain Natriuretic Peptide (BNP) blood samples 7. Cardiac markers samples CONDITION: Coronary Heart Disease ; Circulatory System ; Coronary Heart Disease PRIMARY OUTCOME: 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 OUTCOME: 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 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
Epistemonikos ID: 0e07109f2ad42dda0db6e2a14742f9bda97f7ec4
First added on: Aug 21, 2024