Clinical Trials Directory

Trials / Completed

CompletedNCT02795624

Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

Status
Completed
Phase
Study type
Observational
Enrollment
300 (actual)
Sponsor
Cedars-Sinai Medical Center · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESpirometryTest is done to assess how well the lungs work by measuring how much air is inhaled, how much is exhaled, and how quickly it is exhaled.
PROCEDUREPulse Wave AnalysisIt is a non-invasive assessment of the pulse character
PROCEDUREPeripheral arterial tonometryIt is a non-invasive method to measure endothelial dysfunction.

Timeline

Start date
2016-02-01
Primary completion
2021-08-01
Completion
2021-08-01
First posted
2016-06-10
Last updated
2021-08-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02795624. Inclusion in this directory is not an endorsement.