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临床试验/NCT02795624
NCT02795624已完成不适用

Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Arterial Stiffness (PWV)

研究概览

简要总结

Specific Aim 1. Characterize the long-term effects of secondhand smoke (SHS) on vascular health in pre-ban flight attendants (FAs). Investigators will measure arterial stiffness (pulse wave velocity and augmentation index) and endothelial dysfunction (reactive hyperemia index) in the pre-ban FA cases, and compare to the cardiovascular risk-factor matched Framingham controls.

It is hypothesized that pre-ban FA cases have increased arterial stiffness (higher pulse wave velocity and higher augmentation index) and increased endothelial dysfunction (lower reactive hyperemia index) compared to Framingham controls.

Specific Aim 2. Determine the extent in which remote pre-ban SHS exposure (hours) is associated with increased arterial stiffness or endothelial dysfunction.

Investigators hypothesize that pre-ban SHS exposure is positively associated with both increased arterial stiffness and increased endothelial dysfunction.

Specific Aim 3. Investigators will calculate the cardiovascular risk scores (Framingham, Reynolds, and ASCVD) by using subjects' age, blood pressure, family history, lipid panel, and highly sensitive C-reactive protein. Investigators will explore the association of the risk scores with measures of vascular aging (arterial stiffness and endothelial dysfunction). These scores do not include SHS exposure. Investigators will also test the additive value of SHS exposure in increasing arterial stiffness and endothelial dysfunction using the risk scores as an adjustment value.

It is hypothesized that the cardiovascular risk scores are associated with vascular aging (arterial stiffness and endothelial dysfunction), and that the association between SHS exposure and vascular aging remains significant after adjusting for the cardiovascular risk scores.

The significance of this proposal and impact will be (1) mechanistic insights into how remote SHS exposure leads to hypertension and vascular stiffness, (2) increased understanding of how SHS exposure can increase risk of cardiovascular disease, which is the number one cause of death in the United States.

详细描述

The investigators propose a cohort study, in which investigators will assess for evidence of accelerated vascular aging in 300 pre-ban FAs with pre-ban SHS exposure, and compare their vascular measures of arterial stiffness and endothelial dysfunction to those of age and risk-factor matched Framingham controls. It is hypothesized that pre-ban FAs have increased arterial stiffness and endothelial dysfunction compared to the Framingham subjects, related to SHS exposure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 40 years of age and older;
  • Flight attendant, including current or past employment with the airlines;
  • Non-smoking flight attendant (current and prior, defined as smoking <100 cigarettes in your lifetime);
  • Exposed to secondhand tobacco smoke for at least one year, while working on the aircrafts

排除标准

  • History of Raynaud's syndrome
  • Had mastectomy or arm/hand abnormality in which blood pressure cannot be measured on the arm

结局指标

主要结局

Arterial Stiffness (PWV)

时间窗: Baseline

During Pulse Wave analysis, pulse wave velocity (PWV) will be measured

Arterial Stiffness (AIx)

时间窗: Baseline

During Pulse Wave analysis, augmentation index (AIx) wil be measured

Endothelial Dysfunction (RHI)

时间窗: Baseline

Reactive hyperemia index (RHI) will be measured by Peripheral Arterial Tonometry, which reflects endothelial dysfunction

次要结局

  • Cardiovascular risk(Baseline)

研究者

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

Noel Bairey Merz

Director

Cedars-Sinai Medical Center

研究点 (1)

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