Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure

Not Applicable

Completed

Conditions: Cardiac disease/coronary surgery
Circulatory System
Heart failure

Registration Number: ISRCTN71717097

Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Mid-term generic and cardiac-specific health status and quality of life, measured at baseline and 6 months follow-up<br>2. End systolic volume and stroke volume quantified by cardiac MRI, measured at baseline (3 - 5 days post-operatively) and 6 months follow-up<br>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)