Contact information
Type
Scientific
Primary contact
Mr Raimondo Ascione
ORCID ID
Contact details
Level 7
Research Floor
University of Bristol
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom
-
R.Ascione@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CS/2008/3027
Study information
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
Acronym
TransACT 2
Study hypothesis
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
NHS Southmead Research Ethics Committee, 20/07/2005, ref: 05/K2002/49
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/08/2009
Overall trial end date
01/02/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/08/2009
Recruitment end date
01/02/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Level 7, Research Floor
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
University Hospitals Bristol NHS Foundation Trust (UK)
Sponsor details
Research and Effectiveness Department
Education Centre
Level 3
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
-
jake.hartley@ubht.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit
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