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临床试验/NCT05492071
NCT05492071已完成不适用

Vibration Mediated Dilation and Flow Mediated Dilation in Human Circulatory System

Istanbul University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Brachial Artery Diameter

研究概览

简要总结

Application of vibration has been previously shown to affect tissue perfusion and utilized in different branches of medicine. Little is known about the acute impact of vibration application on peripheral artery hemodynamics. In this study, investigators intend to assess:

  1. vibration induced hemodynamic changes in brachial artery in non-diabetic patients and compare the characteristics of these alterations with flow mediated dilation mediated changes in same cohort.
  2. compare the characteristics of vibration mediated hemodynamic alterations in diabetic and non-diabetic subgroups.

详细描述

Background and Rationale:

Vibration application has been previously shown to affect tissue perfusion and utilized in different branches of medicine. However, previous studies have mainly focused on the impact of vibration on skin perfusion or vibration with active muscle contractions, therefore couldn't truly demonstrate acute impact of local vibration application on peripheral arteries. In addition to that, as a population that is prone to develop vascular problems, it is not known whether diabetic patients have comparable response to vibration application with non-diabetic population.

Objectives:

In this study, investigators aim to demonstrate and compare hemodynamic alterations in brachial artery with paired measurements pre- and post- vibration application and compare the characteristics of these changes with those of flow-mediated dilation in a non-diabetic cohort. Additionally, differences and similarities in vascular hemodynamic response to vibration in diabetic and non-diabetic subgroups are intended to be elucidated.

Methods:

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sinus Rhythm in ECG
  • Ejection Fraction > %35
  • Informed Consent

排除标准

  • Unstabile angina
  • Certain or suspected subclavian artery or brachial artery atherosclerotic disease (assessed with USG)
  • Heart failure ( New York Heart Association III - IV)
  • Atrial fibrillation or frequent extrasystoles in ECG.

结局指标

主要结局

Brachial Artery Diameter

时间窗: Up to 10 minutes after vibration application initiation

vessel diameter in millimeters

Brachial Artery Mean Flow Velocity

时间窗: Up to 10 minutes after vibration application initiation

Mean flow velocity ( cm/sec) measured with Doppler

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Murat Sezer

Professor, MD

Istanbul University

研究点 (2)

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