Efficacy of the mode of delivery of autologous bone marrow cells into heart scar muscle for the recovery of contractile function
| ISRCTN | ISRCTN47591706 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47591706 |
| Protocol serial number | N0523154398 |
| Sponsor | Department of Health |
| Funder | Good Hope Hospital NHS Trust (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 05/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Francisco Leyva
Scientific
Scientific
Consultant Cardiologist
Good Hope Hospital NHS Trust
Rectory Road
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Study the efficacy of the intravascular as compared to intramuscular administration of autologous bone marrow in the reduction of scar tissue in the heart muscle and in the improvement of segmental contactile function |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Coronary artery bypass grafting (CABG) |
| Intervention | [A] Control group receiving only myocardial revascularisation [B] Direct injection into the scar muscle of self bone marrow mononuclear cells in addition to myocardial revascularisation [C] Intravascular administration of self bone marrow into the graft used for myocardial revascularisation |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Functional improvement, and reduction in size of scar areas. The study will also establish whether the number and the type of transplanted bone marrow mononuclear cells is correlated with the recovery of contractile function by performing multiple linear regression analysis. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 07/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Not Specified |
| Target sample size at registration | 90 |
| Key inclusion criteria | Patients undergoing coronary bypass graft surgery aged between 18 and 80. Estimated 30 patients per group in order to detect significance |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 07/04/2004 |
| Date of final enrolment | 07/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Consultant Cardiologist
Birmingham
B75 7RR
United Kingdom
B75 7RR
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No |
