Percutaneous Randomised Infusion of Marrow Aspirate To Improve Ventricular Efficiency

Completed

• Conditions: Coronary Heart Disease; Circulatory System

• Registration Number: ISRCTN74381875
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Aged 18 - 80 years
2. Acute myocardial infarction with chest pain, ST segment elevation >0.2 mV in more than two contiguous leads, peak Creatine Kinase (CK) >600 U/l, for MB isoenzyme
3. First documented Acute Myocardial Infarction (AMI)
4. Referred for rescue Percutaneous Coronary Intervention (PCI)
5. Thrombolysis In Myocardial Infarction (TIMI) grade three flow in infarct related artery following PCI
5. Ejection Fraction (EF) less than 45% following standard treatment
6. No plans for additional revascularisation during the course of the study

Exclusion Criteria

1. TIMI grade zero or one flow despite intervention
2. Chronic inflammatory disease
3. Non-Infarct Related Artery (IRA) revascularisation likely over coming six months
4. Cerebral infarction within past year
5. More than 70% stenosis in non-IRA
6. Active infection (clinical/C-Reactive Protein (CRP)/White Blood Cells (WBC)/blood culture)
7. EF more than 45% following standard treatment
8. Known Human Immunodeficiency Virus (HIV) infection
9. Documented Previous Myocardial Infarction (MI)
10. Renal impairment (creatinine >180 mmol/l)
11. Previous Coronary Artery Bypass Graft (CABG)/PCI
12. Liver dysfunction (abnormal Liver Function Test or International Normalized Ratio (INR) >1.5)
13. Cardiogenic shock at presentation
14. Anaemia (haemaglobin less than 8.5 mg/dl)
15. History of neoplastic disease
16. Low platelet count (less than 100.000 µl)
17. History of hereditary bleeding disorder
18. History of gastro-intestinal bleeding within past three months
19. Major surgery/trauma within past two months
20. Women with childbearing potential
21. Arteriovenous Malformation (AVM)/aneurysms

Study & Design

• Study Type: Interventional
• Study Design: Not specified