Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02673957




Registration number
NCT02673957
Ethics application status
Date submitted
1/02/2016
Date registered
4/02/2016
Date last updated
17/12/2020

Titles & IDs
Public title
Analysis of Local and Circulating Compounds Released Following Blood Pressure Cuff Inflation
Scientific title
Analysis of Local and Circulating Compounds Released Following Hypoxia Induced by Blood Pressure Cuff Inflation
Secondary ID [1] 0 0
HE15-280
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Blood pressure cuff protocol

Blood pressure cuff protocol - All participants receive a baseline control blood test, and all participants receive the blood pressure cuff inflation protocol and blood sampling following the cuff protocol.


Other interventions: Blood pressure cuff protocol
4 cycles of pneumatic blood pressure cuff inflation to 200mmHg for 5 minutes followed by 5 minutes of deflation. Each subsequent cycles commences as soon as the previous cycle is completed.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in local and circulating compounds following blood pressure cuff occlusion protocol
Timepoint [1] 0 0
Last blood sample collected 10 minutes following completion of protocol

Eligibility
Key inclusion criteria
- healthy with no known chronic medical conditions

- low cardiovascular risk

- no recent significant illness or injury

- able to provide informed consent
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- pregnancy or breastfeeding

- moderate or high cardiovascular risk

- chronic medical condition

- taking regular or recent medication, including herbal remedies, recreational drugs or
over-the-counter medication

- smoking within the previous 12 months

- previous or current vascular disorders including deep vein thrombosis

- bleeding disorders

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2017
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New England - Armidale
Recruitment postcode(s) [1] 0 0
2351 - Armidale

Funding & Sponsors
Primary sponsor type
Other
Name
University of New England, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study aims to analyze the way the human body responds to a temporary lack of oxygen, or
ischaemia. Prospective participants will complete a health screen to confirm overall health /
low cardiovascular risk profile.The participants will be required to have pneumatic blood
pressure cuff inflation to 200mmHg on the upper arm for 5 minutes which will then be deflated
for 5 minutes and then repeating the cycle of inflation and deflation a further 3 times.
Blood tests from veins in the forearm would be taken before, during, and after this is done
in order to compare results and establish any change in concentration of local and
circulating compounds.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02673957
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil Smart, PhD M.Med Sci
Address 0 0
University of New England
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02673957