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临床试验/NCT02982044
NCT02982044已完成不适用

Endothelial Function Responses to Manipulations in Blood Flow Pattern

McMaster University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Brachial artery flow-mediated dilation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

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

排除标准

  • •Cardiovascular, musculoskeletal, or metabolic disease

研究组 & 干预措施

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.

干预措施: Suprasystolic (300 mmHg) cuff compressions (Other)

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.

干预措施: Handgrip exercise (Other)

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.

干预措施: Passive heat stress (Other)

结局指标

主要结局

Brachial artery flow-mediated dilation

时间窗: Up to 2 weeks

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

次要结局

  • Endothelial shear rate(Up to 2 weeks)
  • Oscillatory shear index(Up to 2 weeks)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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