Condition category
Circulatory System
Date applied
31/05/2006
Date assigned
20/07/2006
Last edited
05/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Gershlick

ORCID ID

Contact details

Cardiology Department
Clinical Sciences
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+44 (0) 116 256 3049
agershlick@aol.com

Additional identifiers

EudraCT number

2006-003319-39

ClinicalTrials.gov number

Protocol/serial number

UHL 9981

Study information

Scientific title

Acronym

The PRIMATIVE Study

Study hypothesis

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

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.

Study design

Randomised, double blind, interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/07/2006

Overall trial end date

01/07/2009

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/07/2006

Recruitment end date

01/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiology Department
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

University Hospitals of Leicester
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
+44 (0) 116 258 4109
john.hampton@uhl-tr.nhs.uk

Sponsor type

University/education

Website

http://www.uhl-tr.uk/research

Funders

Funder type

University/education

Funder name

University Hospitals of Leicester NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes