Cardiac disease/coronary surgery Circulatory System Heart failure
Conditions
Interventions
Eligible patients undergoing SVR surgery will be allocated to either:
1. Intervention group: SVR surgery and transplantation of autologous CD133+
2. Control group: SVR surgery and injection of placebo
Sponsors
University Hospitals Bristol NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Previous anterior myocardial infarction (with evidence of large surgically excludible scar at cardiac magnetic resonance imaging [MRI]) 2. Significant LV dilation (left ventricular end-systolic volume index [LVESVI] greater than or equal to 60 ml/m^2 3. Left ventricular ejection fraction less than or equal to 35% 4. New York Heart Association (NYHA) class III/IV and one episode of congestive heart failure (CHF) requiring medical attention 5. Elective left ventricular restoration surgery indicated 6. Elective CABG indicated to bypass stenoses or occlusions of coronary arteries 7. Patient aged 16 years or over and under 80 years old, either sex
Exclusion criteria
Exclusion criteria: 1. Severe acute renal failure requiring dialysis or serum creatinine greater than or equal to 200 mmol/L 2. Atrial fibrillation 3. Malignancy 4. Debilitating neurological disease 5. Emergency operation for unstable angina 6. Previous cardiac surgery/sternotomy 7. Concomitant valve procedures 8. History of significant ventricular arrhythmias 9. History of pacemaker and/or defibrillator insertion 10. Right ventricular (RV) failure 11. Pulmonary hypertension greater than 60 mmHg (angiogram or Elixis) 12. Known active infection 13. Chronic inflammatory disease 14. Contraindication for bone marrow aspiration 15. Female subjects of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regional LV thickening of the 'affected' segments 6 months after surgery, i.e. end systolic thickness minus end diastolic thickness (millimetres). Affected segments will be those scored on the cardiac MRI taken 3 - 5 days after surgery, as 1 - 5 (dysfunctional) on a 5-point scale. Affected segments will be the segments which the surgeons aims to inject with stem cells or plasma. Measured at baseline (3 - 5 days post-operatively) and 6 months follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mid-term generic and cardiac-specific health status and quality of life, measured at baseline and 6 months follow-up 2. End systolic volume and stroke volume quantified by cardiac MRI, measured at baseline (3 - 5 days post-operatively) and 6 months follow-up 3. Myocardial injury throughout the duration of the study by measuring troponin I levels (24 hours pre-operatively, surgery, 4, 12, 24 hours post-operatively, 6 weeks and 6 months follow-up) | — |
Countries
United Kingdom
Outcome results
None listed