Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000535774
Ethics application status
Not yet submitted
Date submitted
12/05/2013
Date registered
14/05/2013
Date last updated
14/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of remote ischaemic preconditioning on the late immune response and nervous system
Scientific title
The effect of remote ischaemic preconditioning on the second window immune response and parasympathetic nervous system in healthy volunteers
Secondary ID [1] 282482 0
None
Universal Trial Number (UTN)
U1111-1142-8797
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Remote ischaemic preconditioning is primarily intended for use in cardiac surgery patients 289115 0
Condition category
Condition code
Cardiovascular 289448 289448 0 0
Coronary heart disease
Surgery 289449 289449 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Remote ischaemic preconditioning will be performed at the start of the study. A blood pressure cuff will be placed on the non-dominant upper arm and inflated to 200 mmHg for five minutes, then deflated for five minutes. This cycle will be performed three times immediately one after the other, taking a total of thirty minutes. Follow-up will take place up to 24 hours post-treatment.
Intervention code [1] 287131 0
Other interventions
Comparator / control treatment
The difference between the baseline and post-treatment measurements will be used to determine the effects of the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289551 0
Inflammatory cytokine levels in serum, and leukocyte cultures, quantified using a cytometric bead array and flow cytometry
Timepoint [1] 289551 0
Baseline and 24 hours post-treatment
Primary outcome [2] 289570 0
Changes in heart rate variability, assessed using standard power spectral analysis approaches
Timepoint [2] 289570 0
Baseline and 24 hours post-treatment
Secondary outcome [1] 302717 0
Changes in the size and activation state of leukocyte populations, as determined using flow cytometry
Timepoint [1] 302717 0
Baseline and 24 hours post-treatment
Secondary outcome [2] 302718 0
Changes in apoptosis of peripheral leukocytes, as determined by flow cytometry
Timepoint [2] 302718 0
Baseline and 24 hours post-treatment

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
30 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Peripheral vascular disease
Smoking
Regular use of medication
Acute illness (within 1 week of the study visits)
Any cardiac rhythm abnormality
Any condition affecting the autonomic nervous system (eg diabetes, autonomic neuropathy)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be sent an information sheet about the study and informed consent will be obtained prior to treatment on the day of the first study visit. All participants will receive the same treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
At present there is no data on which to perform a statistical power calculation for this study; however, based on the experience with our previous study and the endpoints being used, it is expected that 10 or more participants will provide sufficient power to detect the magnitude of effect required to be of clinical interest. Changes in endpoints between the baseline and 24 hour post-RIPC samples will be assessed using two-tailed t-tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 5073 0
New Zealand
State/province [1] 5073 0

Funding & Sponsors
Funding source category [1] 287266 0
Charities/Societies/Foundations
Name [1] 287266 0
Wellington Medical Research Foundation
Country [1] 287266 0
New Zealand
Primary sponsor type
Individual
Name
Jenni Williams
Address
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 286019 0
None
Name [1] 286019 0
Address [1] 286019 0
Country [1] 286019 0
Other collaborator category [1] 277393 0
Individual
Name [1] 277393 0
A/Prof Anne La Flamme
Address [1] 277393 0
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
Country [1] 277393 0
New Zealand
Other collaborator category [2] 277394 0
Individual
Name [2] 277394 0
Prof Richard Beasley
Address [2] 277394 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country [2] 277394 0
New Zealand
Other collaborator category [3] 277395 0
Individual
Name [3] 277395 0
A/Prof Peter Larsen
Address [3] 277395 0
Department of Surgery & Anaesthesia
University of Otago, Wellington
PO Box 7343
Wellington South
Country [3] 277395 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289245 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 289245 0
PO Box 5013
Wellington 6145
Ethics committee country [1] 289245 0
New Zealand
Date submitted for ethics approval [1] 289245 0
16/05/2013
Approval date [1] 289245 0
Ethics approval number [1] 289245 0

Summary
Brief summary
Remote ischaemic preconditioning (RIPC) is the phenomenon where brief periods of ischaemia (reduced oxygen delivery) in one organ can have a protective effect against subsequent ischaemia in other organs. There are two periods of protection provided by RIPC. The first occurs within minutes and lasts between two and four hours, whereas the second presents 24 hours after the conditioning and persists for up to 72 hours. The exact mechanisms through which RIPC exerts these protective periods are unclear; however, there is evidence to support the involvement of both immune and nervous pathways.
This study will investigate the effect of RIPC on the immune response during the late phase of protection, and on the immediate parasympathetic nervous response. This will be achieved by recruiting 15 healthy male volunteers and collecting blood samples and electrocardiogram traces of the electrical activity of the heart before, and 24 hours after, RIPC. The blood samples will be used to measure the effect of RIPC on inflammatory biomarker levels and the function of circulating white blood cells. The ECGs will be used to determine if the RIPC stimulates the parasympathetic nervous system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39934 0
Miss Jenni Williams
Address 39934 0
School of Biological Sciences,
Victoria University of Wellington,
PO Box 600,
Wellington 6140
Country 39934 0
New Zealand
Phone 39934 0
+64 4 463 6559
Fax 39934 0
Email 39934 0
[email protected]
Contact person for public queries
Name 39935 0
Miss Jenni Williams
Address 39935 0
School of Biological Sciences,
Victoria University of Wellington,
PO Box 600,
Wellington 6140
Country 39935 0
New Zealand
Phone 39935 0
+64 4 463 6559
Fax 39935 0
Email 39935 0
[email protected]
Contact person for scientific queries
Name 39936 0
Miss Jenni Williams
Address 39936 0
School of Biological Sciences,
Victoria University of Wellington,
PO Box 600,
Wellington 6140
Country 39936 0
New Zealand
Phone 39936 0
+64 4 463 6559
Fax 39936 0
Email 39936 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.