Selected autologous bone marrow cell transplant following trans-mural myocardial infarction in patients undergoing coronary surgery: A prospective, double-blind, randomised controlled trial

Completed

Conditions: Cardiac disease/ coronary surgery
Circulatory System
Acute myocardial infarction

Registration Number: ISRCTN65630838

Lead Sponsor: nited Bristol Healthcare NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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

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 <50% wall thickness in all 7 segments of the LAD territory
3. Presence of LV dilatation (LV end systolic volume index >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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The following outcomes will be measured pre-operatively and at 6 months after surgery:<br>1. Scar distribution and the viability of the myocardium with MRI <br>2. LV segmental and global function with echocardiography <br>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) <br>4. Myocardial injury throughout the entire study period by measuring troponin I levels