IschemiaNCT02673957
Analysis of Local and Circulating Compounds Released Following Blood Pressure Cuff Inflation
An observational study of Ischemia, run by University of New England, Australia at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemia
- What is being tested?
- Blood pressure cuff protocol
- How many people
- 6 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants
Who may be able to join
- healthy with no known chronic medical conditions
- low cardiovascular risk
- no recent significant illness or injury
- able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Local and Circulating Compounds Released Following Hypoxia Induced by Blood Pressure Cuff Inflation
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.
Read the 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.
- Conditions
- Ischemia
- Being tested
- Blood pressure cuff protocol
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure cuff protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood pressure cuff protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in local and circulating compounds following blood pressure cuff occlusion protocol
Extracted plasma from venous blood samples will be analyzed by mass spectrometry to assess for any changes when compared with baseline blood test
Measured: Last blood sample collected 10 minutes following completion of protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New England, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Epps, University of New England
- Investigators
- Neil Smart, PhD M.Med Sci, Study chair, University of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673957
- Sponsor's protocol ID
- HE15-280
- Status last verified
- Dec 2020
- First submitted
- 1 Feb 2016
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Local and Circulating Compounds Released Following Hypoxia Induced by Blood Pressure Cuff Inflation
- ClinicalTrials.gov ID
- NCT02673957
- Acronym / sponsor ID
- HE15-280
- Conditions
- Ischemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of New England, AustraliaUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood pressure cuff protocol | – | Other: Blood pressure cuff protocolAll participants receive a baseline control blood test, and all participants receive the blood pressure cuff inflation protocol and blood sampling following the cuff protocol. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants
Key inclusion criteria (4 listed)
- healthy with no known chronic medical conditions
- low cardiovascular risk
- no recent significant illness or injury
- able to provide informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure cuff protocol4 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. | Other | Blood pressure cuff protocol |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Smart, PhD M.Med Sci study chair
University of New England
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia, run by University of New England, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in local and circulating compounds following blood pressure cuff occlusion protocol (time frame: Last blood sample collected 10 minutes following completion of protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.