Percutaneous Randomised Infusion of Marrow Aspirate To Improve Ventricular Efficiency

ISRCTN	ISRCTN74381875
DOI	https://doi.org/10.1186/ISRCTN74381875
Clinical Trials Information System (CTIS)	2006-003319-39
Protocol serial number	UHL 9981
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	University Hospitals of Leicester NHS Trust (UK)

Submission date: 31/05/2006
Registration date: 20/07/2006
Last edited: 05/04/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anthony Gershlick
Scientific

Cardiology Department
Clinical Sciences
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Phone	+44 (0) 116 256 3049
Email	agershlick@aol.com

Study information

Primary study design	Interventional
Study design	Randomised, double blind, interventional study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The PRIMATIVE Study
Study objectives	Autologous bone-marrow derived stem cells delivered percutaneously to the damaged myocardium via the heart attack related artery can significantly improve left sided heart function after a heart attack without significant adverse effects. This impact is evident even if the bone marrow cells are delivered late after the index event.
Ethics approval(s)	Ethics approval received from the Leicestershire, Northamptonshire and Rutland Committee 1 on the 12th December 2006 (ref: 06/Q2502/58). EudraCT number: 2006-003319-39.
Health condition(s) or problem(s) studied	Coronary Heart Disease
Intervention	Status of trial amended to 'stopped' as of 05/04/2013 due to notification that it was not started. The control group will receive a placebo stem cell transfusion made up of autologous heparinised plasma and the study group will receive autologous Stem Cell Therapy (SCT). The following measurements will be made: 1. Coronary Angiogram 2. Four Magnetic Resonance Imaging (MRI) scans 3. Bone marrow cell aspiration 4. Stem cell transfusion 5. Holter monitoring 6. Atrial Natriuretic Peptide (ANP)/Brain Natriuretic Peptide (BNP) blood samples 7. Cardiac markers samples
Intervention type	Other
Primary outcome measure(s)	Improvement in left ventricular function is determined by the comparison of the mean left ventricular EF in the stem cell treated and control groups, measured on initial MRI and that at four months in the early stem cell group and comparison of mean left ventricular EF measured at four months and one year in stem cell treated and control in the late treatment group. Maintenance of benefit will be assessed by comparison of EF at 12 months in subjects randomised to SCT in the early treatment group.
Key secondary outcome measure(s)	1. All cause and cardiac mortality at 12 months 2. Troponin and CK enzyme rise at 12 months post all interventional procedures 3. Hospitalisation for heart failure (symptoms of dyspnoea at minimal effort or at rest despite conventional treatment) at twelve months 4. Recurrent MI within 12 months 5. Need for revascularisation (exercise tolerance test positive)(PCI/CABG) to Target Lesion Revascularisation (TLR) and non-TLR at four and 12 months 6. Hospitalisation for arrythmias 7. Presence of malignant arrythmias (ventricular fibrillation, ventricular tachycardia, frequent ventricular ectopics) on 24 hour Electro cardiogram (ECG) monitoring at one, six and 12 months 8. ANP/BNP measured at baseline, four and 12 months 9. Inflammatory status (full blood leucocytes count and C-Reactive Protein performed pre- and post- SCT) 10. Scar size assessed by Gadolinum enhanced MRI scans in 50% each group
Completion date	01/07/2009
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	01/07/2006
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cardiology Department

Leicester
LE3 9QP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan