Contact information
Type
Scientific
Primary contact
Prof S Homer-Vanniasinkam
ORCID ID
Contact details
Vascular Surgical Unit
Clarendon Wing
Leeds Teaching Hospitals NHS Trust
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2947
shervanthi.homer-vanniasinkam@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436130382
Study information
Scientific title
Study into the effects of ischaemic pre-conditioning (IPC) on ischaemia-reperfusion injury (IRI) in patients with peripheral vascular disease
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/04/2003
Overall trial end date
01/04/2005
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2003
Recruitment end date
01/04/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Vascular Surgical Unit
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leeds Teaching Hospitals NHS Trust UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary