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临床试验/NCT05454267
NCT05454267招募中不适用

Early Detection of Vaping-related Vascular Diseases

University of Miami2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
2
主要终点
Airway blood flow reactivity (QAW)

研究概览

简要总结

The purpose of this study is to determine how vaping affects blood vessels, in particular if early damage occurs in the lung vessels.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Vapers Group:
  • Current electronic cigarette (EC) Puff Bar users defined as using EC either daily or occasionally in the past 30 days for at least 6 months, and with 5% nicotine concentration pods.
  • Adults aged 18-40 years
  • Healthy Group:
  • Healthy never smokers, never vapers
  • Adults aged 18-40 years

排除标准

  • Current or past smoking of tobacco cigarette (TC) or other tobacco/nicotine products (e.g., smokeless tobacco, Hookah) or marijuana will be excluded from the study.
  • Subjects with self-reported history of chronic health problems including asthma, chronic obstructive pulmonary disease (COPD), morbid obesity (BMI>40 kg/m2), hypertension or diabetes
  • Pregnant or breastfeeding women

研究组 & 干预措施

Healthy Volunteer Group

Participants who have never smoked or vaped

High Frequency Vaping Group

Participants who vape >20 days per month.

Low-Frequency Vaping Group

Participants who vape < 20 days per month

结局指标

主要结局

Airway blood flow reactivity (QAW)

时间窗: Up to 1 week

QAW will be measured via soluble gas uptake method

Pulmonary vascular resistance (PVR)

时间窗: Up to 4 weeks

PVR will be measured via echocardiography

Flow-mediated vasodilation (FMD)

时间窗: Up to 4 weeks

FMD will be measured by blood pressure cuff deflation using ultrasound

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

Adam Wanner

Professor of Medicine

University of Miami

研究点 (2)

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Early Detection of Vaping-related Vascular Diseases | 临床试验