Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure

ISRCTN	ISRCTN71717097
DOI	https://doi.org/10.1186/ISRCTN71717097
Secondary identifying numbers	CS/2008/3027

Submission date: 27/07/2009
Registration date: 14/10/2009
Last edited: 12/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
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

Mr Raimondo Ascione
Scientific

Level 7, Research Floor
University of Bristol
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Email	R.Ascione@bristol.ac.uk

Study information

Study design	Double-blind randomised placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet
Scientific title	Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure: a randomised blinded controlled trial
Study acronym	TransACT 2
Study objectives	The aim of this study is to determine the effects of CD133+ autologous stem cells transplantation in and around asynergic non-viable left ventricular (LV) segments in patients with dilated ischaemic heart disease undergoing left ventricular reshaping surgery and coronary artery bypass graft (CABG).
Ethics approval(s)	NHS Southmead Research Ethics Committee, 20/07/2005, ref: 05/K2002/49
Health condition(s) or problem(s) studied	Cardiac disease/coronary surgery
Intervention	Eligible patients undergoing SVR surgery will be allocated to either: 1. Intervention group: SVR surgery and transplantation of autologous CD133+ 2. Control group: SVR surgery and injection of placebo, i.e. autologous plasma Please use following contact details to request a patient information sheet: Dr Jodi Taylor Clinical Trials Co-ordinator Bristol Heart Institute University of Bristol Level 7, Bristol Royal Infirmary Bristol, BS2 8HW United Kingdom Tel: +44 (0)117 342 3398 Email: j.taylor@bristol.ac.uk
Intervention type	Other
Primary outcome measure	Regional LV thickening of the 'affected' segments 6 months after surgery, i.e. end systolic thickness minus end diastolic thickness (millimetres). Affected segments will be those scored on the cardiac MRI taken 3 - 5 days after surgery, as 1 - 5 (dysfunctional) on a 5-point scale. Affected segments will be the segments which the surgeons aims to inject with stem cells or plasma. Measured at baseline (3 - 5 days post-operatively) and 6 months follow-up.
Secondary outcome measures	1. Mid-term generic and cardiac-specific health status and quality of life, measured at baseline and 6 months follow-up 2. End systolic volume and stroke volume quantified by cardiac MRI, measured at baseline (3 - 5 days post-operatively) and 6 months follow-up 3. Myocardial injury throughout the duration of the study by measuring troponin I levels (24 hours pre-operatively, surgery, 4, 12, 24 hours post-operatively, 6 weeks and 6 months follow-up)
Overall study start date	01/08/2009
Completion date	01/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Previous anterior myocardial infarction (with evidence of large surgically excludible scar at cardiac magnetic resonance imaging [MRI]) 2. Significant LV dilation (left ventricular end-systolic volume index [LVESVI] greater than or equal to 60 ml/m^2 3. Left ventricular ejection fraction less than or equal to 35% 4. New York Heart Association (NYHA) class III/IV and one episode of congestive heart failure (CHF) requiring medical attention 5. Elective left ventricular restoration surgery indicated 6. Elective CABG indicated to bypass stenoses or occlusions of coronary arteries 7. Patient aged 16 years or over and under 80 years old, either sex
Key exclusion criteria	1. Severe acute renal failure requiring dialysis or serum creatinine greater than or equal to 200 mmol/L 2. Atrial fibrillation 3. Malignancy 4. Debilitating neurological disease 5. Emergency operation for unstable angina 6. Previous cardiac surgery/sternotomy 7. Concomitant valve procedures 8. History of significant ventricular arrhythmias 9. History of pacemaker and/or defibrillator insertion 10. Right ventricular (RV) failure 11. Pulmonary hypertension greater than 60 mmHg (angiogram or Elixis) 12. Known active infection 13. Chronic inflammatory disease 14. Contraindication for bone marrow aspiration 15. Female subjects of childbearing potential
Date of first enrolment	01/08/2009
Date of final enrolment	01/02/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Level 7, Research Floor

Bristol
BS2 8HW
United Kingdom

Sponsor information

University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Effectiveness Department
Education Centre, Level 3
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom

Email	jake.hartley@ubht.nhs.uk
Website	http://www.uhbristol.nhs.uk/
"ROR"	https://ror.org/04nm1cv11

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

12/04/2017: No publications found in PubMed, verifying study status with principal investigator.