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Autologous bone marrow-derived cells for cardioprotection during heart surgery

Not Applicable
Conditions
Ischaemic heart disease
Circulatory 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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