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| Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure |
| ISRCTN | ISRCTN71717097 |
| ClinicalTrials.gov identifier | |
| Public title | Bone-marrow derived stem cell transplantation in patients undergoing left ventricular restoration surgery for dilated ischaemic end-stage heart failure |
| 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 |
| Serial number at source | CS/2008/3027 |
| 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). |
| Lay summary | |
| Ethics approval | NHS Southmead Research Ethics Committee approved on the 20th July 2005 (ref: 05/K2002/49) |
| Study design | Double-blind randomised placebo-controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Cardiac disease/coronary surgery |
| Participants - 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 |
| Participants - 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 pace-maker 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 |
| Anticipated start date | 01/08/2009 |
| Anticipated end date | 01/02/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet |
| Target number of participants | 40 |
| Interventions |
Eligible patients undergoing SVR surgery will be allocated to either:
Intervention group: SVR surgery and transplantation of autologous CD133+ 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 |
| Primary outcome measure(s) | 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 measure(s) |
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) |
| Sources of funding | National Institute for Health Research (NIHR) (UK) - Biomedical Research Unit |
| Trial website | |
| Publications | |
| Contact name | Mr Raimondo Ascione |
| Address |
Level 7, Research Floor
University of Bristol Bristol Royal Infirmary |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| R.Ascione@bristol.ac.uk | |
| Sponsor | University Hospitals Bristol NHS Foundation Trust (UK) |
| Address |
Research and Effectiveness Department
Education Centre, Level 3 Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8AE |
| Country | United Kingdom |
| jake.hartley@ubht.nhs.uk | |
| Sponsor website: | http://www.uhbristol.nhs.uk/ |
| Date applied | 27/07/2009 |
| Last edited | 14/10/2009 |
| Date ISRCTN assigned | 14/10/2009 |
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