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Analysis of Local and Circulating Compounds Released Following Blood Pressure Cuff Inflation

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ClinicalTrials.gov Identifier: NCT02673957
Recruitment Status : Terminated (Funding withdrawn)
First Posted : February 4, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Jacqueline Epps, University of New England

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.

Condition or disease Intervention/treatment
Ischemia Other: Blood pressure cuff protocol

Detailed Description:

Evidence exists that short periods of ischaemia (lack of oxygen delivered to tissue in the body) can protect a local or remote area of the body from subsequent prolonged periods of serious ischaemia. It has been shown that substances are released into the circulation after short periods of ischaemia that may cause this protection. This study aims to identify some of these compounds.

After participants are informed about the study and have an opportunity to ask questions, informed consent will be obtained. Following this, a modified Exercise and Sports Science Australia questionnaire and brief medical history will be obtained. Blood pressure readings, height, weight and waist circumference would be measured. This is to establish a picture of overall general health and cardiovascular risk profile.

Those who meet the study eligibility criteria will proceed on a subsequent day to the blood pressure cuff inflation protocol. Consumption of caffeine or alcohol cannot be consumed within 4 hours prior to the protocol and participants must minimise any physical activity in the 4 hours prior to the protocol. After resting for 15 minutes on arrival, a baseline venous blood test will be taken from the dominant arm. A standard pneumatic blood pressure cuff will be placed around the non-dominant upper arm and inflated to 200mmHg for 5 minutes. The cuff will then be deflated completely for 5 minutes. This cycle will be repeated a further 3 times, with each cycle commencing as soon as the previous one has been completed. At the end of the final deflation, a second venous blood sample will be taken from the arm with the cuff. 10 minutes after this, a final venous blood test will be taken from the dominant arm. Blood samples will be processed and stored appropriately until analysed by mass spectrometry. Changes in compounds in the cuffed limb and the opposite limb from the baseline blood sample will be analysed.

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Analysis of Local and Circulating Compounds Released Following Hypoxia Induced by Blood Pressure Cuff Inflation
Actual Study Start Date : February 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Group/Cohort Intervention/treatment
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: 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.




Primary Outcome Measures :
  1. Changes in local and circulating compounds following blood pressure cuff occlusion protocol [ Time Frame: Last blood sample collected 10 minutes following completion of protocol ]
    Extracted plasma from venous blood samples will be analyzed by mass spectrometry to assess for any changes when compared with baseline blood test


Biospecimen Retention:   Samples With DNA
Peripheral venous blood samples, which are processed by centrifuge. The plasma will be extracted and retained for analysis, with the rest of the sample discarded.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy participants
Criteria

Inclusion Criteria:

  • healthy with no known chronic medical conditions
  • low cardiovascular risk
  • no recent significant illness or injury
  • able to provide informed consent

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673957


Locations
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Australia, New South Wales
University of New England
Armidale, New South Wales, Australia, 2351
Sponsors and Collaborators
University of New England
Investigators
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Study Chair: Neil Smart, PhD M.Med Sci University of New England
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Responsible Party: Dr Jacqueline Epps, University of New England
ClinicalTrials.gov Identifier: NCT02673957    
Other Study ID Numbers: HE15-280
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes