Artery Function Responses to Changes in Blood Flow
ASPEN
Endothelial Function Responses to Manipulations in Blood Flow Pattern
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to determine if different blood flow patterns change artery function. We hypothesize that the temporary induction of an oscillatory blood flow pattern will result in an immediate improvement in artery function. Participants will be asked to come to the Vascular Dynamics Lab (IWC E102) at McMaster University for a total of 3 visits. The first visit will allow the participant to get comfortable with the lab and the upcoming tests; and the next 2 visits will be scheduled at the same time of day to collect data. For visits 2 and 3, participants will be asked to arrive after a 4 hour fast. At these visits, ultrasound imaging will be used to examine the arteries and how they may change when blood flow patterns through an artery in the arm are changed. To change blood flow in the arm, heat, rhythmic squeezing of the forearm with a cuff, or handgrip exercise will be used. These interventions will be applied to the left forearm, from the elbow to the fingertips. A trained technician will also draw a blood sample during both data collection visits. A total of 10 participants will be recruited for the entire study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJanuary 18, 2018
January 1, 2018
2 months
November 24, 2016
January 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brachial artery flow-mediated dilation
Collected using vascular ultrasound and analyzed using semi-automated edge-tracking software
Up to 2 weeks
Secondary Outcomes (5)
Mean blood velocity magnitude and direction
Up to 2 weeks
Reynolds number (blood flow turbulence)
Up to 2 weeks
Endothelial shear stress
Up to 2 weeks
Oscillatory shear index
Up to 2 weeks
Endothelial shear rate
Up to 2 weeks
Study Arms (1)
Experimental-Control
EXPERIMENTALParticipants will undergo all interventions, while simultaneously serving as their own within-subject control. The left side of the body will be designated "experimental", and all interventions will be applied to the left arm. The right side of the body will be designated as "control", and will not receive any interventions.
Interventions
10 minutes of ECG-gated repeated suprasystolic (300 mmHg) cuff compressions, with inflation occurring every other heart cycle. These cuff compressions may be triggered 0 seconds, 0.2 seconds, or 0.4 seconds from the R spike (systole) on the ECG signal.
10 minutes of ECG-gated rhythmic handgrip exercise at 30% maximal voluntary contraction, with contraction occurring every other heart cycle
10 minutes of passive heat stress at 42 degrees Celsius with a commercially available heating blanket
Eligibility Criteria
You may qualify if:
- Healthy (no cardiovascular, musculoskeletal, or metabolic disease)
- Male
- years old
- Recreationally active (exercising 2-3 times per week)
You may not qualify if:
- Cardiovascular, musculoskeletal, or metabolic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McMaster University Vascular Dynamics Lab
Hamilton, Ontario, L8S 4L8, Canada
Related Publications (6)
Wang C, Baker BM, Chen CS, Schwartz MA. Endothelial cell sensing of flow direction. Arterioscler Thromb Vasc Biol. 2013 Sep;33(9):2130-6. doi: 10.1161/ATVBAHA.113.301826. Epub 2013 Jun 27.
PMID: 23814115BACKGROUNDTinken TM, Thijssen DH, Hopkins N, Dawson EA, Cable NT, Green DJ. Shear stress mediates endothelial adaptations to exercise training in humans. Hypertension. 2010 Feb;55(2):312-8. doi: 10.1161/HYPERTENSIONAHA.109.146282. Epub 2010 Jan 4.
PMID: 20048193BACKGROUNDThijssen DH, Dawson EA, Black MA, Hopman MT, Cable NT, Green DJ. Brachial artery blood flow responses to different modalities of lower limb exercise. Med Sci Sports Exerc. 2009 May;41(5):1072-9. doi: 10.1249/MSS.0b013e3181923957.
PMID: 19346980BACKGROUNDGurovich AN, Braith RW. Enhanced external counterpulsation creates acute blood flow patterns responsible for improved flow-mediated dilation in humans. Hypertens Res. 2013 Apr;36(4):297-305. doi: 10.1038/hr.2012.169. Epub 2012 Oct 18.
PMID: 23076403BACKGROUNDReneman RS, Arts T, Hoeks AP. Wall shear stress--an important determinant of endothelial cell function and structure--in the arterial system in vivo. Discrepancies with theory. J Vasc Res. 2006;43(3):251-69. doi: 10.1159/000091648. Epub 2006 Feb 20.
PMID: 16491020BACKGROUNDTotosy de Zepetnek JO, Ditor DS, Au JS, MacDonald MJ. Impact of shear rate pattern on upper and lower limb conduit artery endothelial function in both spinal cord-injured and able-bodied men. Exp Physiol. 2015 Oct;100(10):1107-17. doi: 10.1113/EP085056. Epub 2015 Aug 18.
PMID: 26206681BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Maureen J MacDonald, PhD
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2016
First Posted
December 5, 2016
Study Start
January 1, 2017
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
January 18, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share