A pilot study to evaluate the efficacy of combined transplantation of progenitor cells and coronary artery bypass grafting
| ISRCTN | ISRCTN75217135 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75217135 |
| Secondary identifying numbers | N0231134600 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 26/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mr David Varghese
Scientific
Scientific
Level D
East Wing
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)7855 495450 |
|---|---|
| dvarghese@btinternet.com |
Study information
| Study design | Randomised 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 contact details to request a participant information sheet |
| Scientific title | A pilot study to evaluate the efficacy of combined transplantation of progenitor cells and coronary artery bypass grafting (TOPCABG) |
| Study hypothesis | Can the transplanted progenitor cells promote improvements in myocardial function? |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Surgery: Coronary artery bypass grafting (CABG) |
| Intervention | Randomised controlled trial - 5 recipients receiving stem cells and 5 control patients receiving heparinised saline |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Improvements in myocardial function, regional wall motion and myocardial perfusion |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2004 |
| Overall study end date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Participant inclusion criteria | 10 patients undergoing coronary artery bypass grafting |
| Participant exclusion criteria | Does not match inclusion criteria |
| Recruitment start date | 01/01/2004 |
| Recruitment end date | 01/01/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Southampton University Hospitals NHS Trust (UK)
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
26/07/2016: No publications found, verifying study status with principal investigator.
