Autologous bone marrow-derived cells for cardioprotection during heart surgery
- Conditions
- Ischaemic heart diseaseCirculatory System
- Registration Number
- ISRCTN22639386
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust (UK)
- Brief Summary
2004 Abstract results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15040600 2006 Abstract results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17059931 2009 Results article in https://pubmed.ncbi.nlm.nih.gov/19561024/ (added 19/07/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 44
1. Triple vessel coronary artery disease with or without significant disease of the left main stem with indication of elective surgical revascularisation
2. Left ventricular ejection fraction greater than 40%
3. Age 20 to 80 years
In addition to not being compliant to the inclusion criteria, the following criteria will be sufficient to exclude patients from entering the study:
1. Cardiogenic shock (need for inotropic drugs, intra-aortic balloon pump)
2. Previous Coronary Artery Bypass Graft (CABG)
3. Percutaneous Coronary Infusion (PCI) in the previous three months
4. History of neoplastic disease
5. History of bleeding disorder
6. Chronic inflammatory disease
7. Active infection
8. Renal impairment (creatinine more than 180 mmol/l)
9. Liver dysfunction (Glutamate Oxalate Transferase [GOT] more than 2 x Upper Limit of Normal [ULN] or International Normalised Ratio [INR] more than 1.5 x ULN)
10. Diabetes
11. Chronic treatment with oral antibiotic agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method