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 |
| Protocol serial number | N0231134600 |
| Sponsor | Department of Health |
| Funder | Southampton University Hospitals NHS Trust (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 objectives | Can the transplanted progenitor cells promote improvements in myocardial function? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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(s) |
Improvements in myocardial function, regional wall motion and myocardial perfusion |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Key inclusion criteria | 10 patients undergoing coronary artery bypass grafting |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/07/2016: No publications found, verifying study status with principal investigator.
