NCT02982044

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

November 24, 2016

Last Update Submit

January 16, 2018

Conditions

Keywords

blood flowendothelial functionshear stress

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

EXPERIMENTAL

Participants 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.

Other: Suprasystolic (300 mmHg) cuff compressionsOther: Handgrip exerciseOther: Passive heat stress

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.

Experimental-Control

10 minutes of ECG-gated rhythmic handgrip exercise at 30% maximal voluntary contraction, with contraction occurring every other heart cycle

Experimental-Control

10 minutes of passive heat stress at 42 degrees Celsius with a commercially available heating blanket

Experimental-Control

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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: 23814115BACKGROUND
  • Tinken 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: 20048193BACKGROUND
  • Thijssen 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: 19346980BACKGROUND
  • Gurovich 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: 23076403BACKGROUND
  • Reneman 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: 16491020BACKGROUND
  • Totosy 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

  • Maureen J MacDonald, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

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

Locations