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

NCT02673957 | Terminated DMC

• 1 other identifier: HE15-280
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia

Outcome Measures

Primary Outcomes (1)

• 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

  Last blood sample collected 10 minutes following completion of protocol

Study Arms (1)

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

Interventions

Blood pressure cuff protocol OTHER

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.

Blood pressure cuff protocol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participants

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New England, Australia: lead

Study Sites (1)

University of New England

Armidale, New South Wales, 2351, Australia

Location

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.

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neil Smart, PhD M.Med Sci

  University of New England

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Jacqueline Epps

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)