Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

13/09/2016: No publications found in PubMed, verifying study status with principal investigator.