Study into the effects of ischaemic pre-conditioning (IPC) on ischaemia-reperfusion injury (IRI) in patients with peripheral vascular disease
| ISRCTN | ISRCTN18883083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18883083 |
| Secondary identifying numbers | N0436130382 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 13/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Prof S Homer-Vanniasinkam
Scientific
Scientific
Vascular Surgical Unit
Clarendon Wing
Leeds Teaching Hospitals NHS Trust
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 392 2947 |
|---|---|
| shervanthi.homer-vanniasinkam@leedsth.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Study into the effects of ischaemic pre-conditioning (IPC) on ischaemia-reperfusion injury (IRI) in patients with peripheral vascular disease |
| Study objectives | The aim of this study is to show that both local and remote pre-conditioning is protective against reperfusion injury in high risk subjects. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Peripheral vascular disease |
| Intervention | Laboratory study; Randomised controlled trial; Qualitative methodology. Exercise on treadmill until symptoms of reperfusion injury are reproduced. This is preceeded by preconditioning exercises (warm up exercises) in some cases vs no preconditioning exercises in other cases. |
| Intervention type | Other |
| Primary outcome measure | Reduction in complications of reperfusion injury as measured by 1. Metabolites 1.1. Lactate 1.2. Blood pH 1.3. Interleukin 6 (IL-6) 1.4. Heat shock protein (HSP) 1.5. Nitric oxide (NO) 2. Blood constituents 2.1. Activated platelets 2.2. Platelet-leucocyte aggregates |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2003 |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Study group - volunteers selected from patients with peripheral vascular disease (outpatients) who experience symptoms of claudication; control subjects will be age-matched volunteers. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Vascular Surgical Unit
Leeds
LS1 3EX
United Kingdom
LS1 3EX
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
Leeds Teaching 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
13/09/2016: No publications found in PubMed, verifying study status with principal investigator.
