ISRCTN71717097
Completed
未知
Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure: a randomised blinded controlled trial
niversity Hospitals Bristol NHS Foundation Trust (UK)0 sites40 target enrollmentOctober 14, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Hospitals Bristol NHS Foundation Trust (UK)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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