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Completed

NCT Number: NCT02982044

Artery Function Responses to Changes in Blood Flow

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University Vascular Dynamics Lab

Hamilton, Ontario, L8S 4L8, Canada

About this study

Interested individuals will be invited to the lab for a screening and familiarization visit, in which the brachial artery (BA) will be scanned to vet for image quality and a BA flow-mediated dilation test will be performed to ensure participant tolerance during collection visits. All qualified participants will be instructed to refrain from vigorous physical activity > 24 hours, alcohol and caffeine > 6 hours, and food > 4 hours prior to each of the two collection visits. Upon arrival, basic anthropometric measures will be collected and hematocrit will be measured in duplicate with a finger prick blood sample equivalent to two 70 µl capillary tubes. Each of the two data collection visits will begin 10 minutes of supine rest, while the participant is instrumented with skin temperature probes on the forearms and hands for measurement of skin temperature, single-lead ECG (Powerlab model ML795, ADInstruments, Colorado Springs, CO, USA) and non-invasive finger cuff (Finometer MIDI, Finapres, The Netherlands) for continuous heart rate and blood pressure monitoring. On the first data collection visit, following rest, the participant will then undergo three 10-minute interventions applied to the left forearm in the following sequence: (1) ECG-gated suprasystolic (300 mmHg) cuff compressions with inflation occurring every other heart cycle, (2) 42 °C heating with a heating blanket, and (3) ECG-gated rhythmic handgrip exercise at 30% MVC with contraction occurring every other heart cycle. 10-minute rest periods will separate each of the interventions to allow for return to baseline conditions. On the second data collection visit, following rest, the participant will undergo three variations of the 10-minute cuff compression intervention, the order of which will be randomized. The three variations differ in the trigger delay from the R spike of the ECG to cause inflation of the cuff for compressions. The original intervention involves the data acquisition unit triggering inflation of the cuff at systole (R spike) (0s delay). This condition will be compared to two other trigger delays, specifically triggering inflation of the cuff at 0.2s and 0.4s after the R spike. For both data collection visits, BA blood velocities, blood flow turbulence, endothelial shear stress, and oscillatory shear index will be assessed before and during each of the interventions; and relative flow-mediated dilation will be assessed before and immediately after each of the interventions. Participants will provide written informed consent prior to beginning any portion of the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy (no cardiovascular, musculoskeletal, or metabolic disease)
  • Male
  • 18-35 years old
  • Recreationally active (exercising 2-3 times per week)

Exclusion criteria

  • Cardiovascular, musculoskeletal, or metabolic disease

Treatment and study plan

Suprasystolic (300 mmHg) cuff compressions

Other

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.

Handgrip exercise

Other

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

Passive heat stress

Other

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

Primary outcomes

  1. Brachial artery flow-mediated dilation

    Time frame: Up to 2 weeks

    Collected using vascular ultrasound and analyzed using semi-automated edge-tracking software

Secondary outcomes

  1. Mean blood velocity magnitude and direction

    Time frame: Up to 2 weeks

    Collected using vascular ultrasound and sent to spectral analyzer for calculation of intensity-weighted mean

  2. Reynolds number (blood flow turbulence)

    Time frame: Up to 2 weeks

    Calculated using blood velocity and artery diameter obtained from vascular ultrasound, and blood density and viscosity calculated using hematocrit

  3. Endothelial shear stress

    Time frame: Up to 2 weeks

    Calculated using blood velocity and artery diameter obtained from vascular ultrasound, and blood viscosity calculated using hematocrit

  4. Oscillatory shear index

    Time frame: Up to 2 weeks

    Calculated using blood velocity and artery diameter obtained from vascular ultrasound

  5. Endothelial shear rate

    Time frame: Up to 2 weeks

    Calculated using blood velocity and artery diameter obtained from vascular ultrasound

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Natural Sciences and Engineering Research Council, Canada

Registry information

Official study title

Endothelial Function Responses to Manipulations in Blood Flow Pattern

Acronym: ASPEN

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2016
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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