Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

August 19, 2021 updated by: Noel Bairey Merz, Cedars-Sinai Medical Center

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Women's Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Flight attendants that are 40 years of age and older, with prior occupation secondhand smoke (SHS) exposure pre- and post- smoking ban.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Flight attendants
Test 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.
Other Names:
  • Breathing test
It is a non-invasive assessment of the pulse character
Other Names:
  • PWA
  • Arterial stiffness test
It is a non-invasive method to measure endothelial dysfunction.
Other Names:
  • Endothelial function test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Dysfunction (RHI)
Time Frame: Baseline
Reactive hyperemia index (RHI) will be measured by Peripheral Arterial Tonometry, which reflects endothelial dysfunction
Baseline
Arterial Stiffness (PWV)
Time Frame: Baseline
During Pulse Wave analysis, pulse wave velocity (PWV) will be measured
Baseline
Arterial Stiffness (AIx)
Time Frame: Baseline
During Pulse Wave analysis, augmentation index (AIx) wil be measured
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk
Time Frame: Baseline
Framingham 10-year risk
Baseline
Cardiovascular risk
Time Frame: Baseline
Reynolds 10-year risk
Baseline
Cardiovascular risk
Time Frame: Baseline
American Heart Association/ACC 10-year risk
Baseline
Cardiovascular risk
Time Frame: Baseline
American Heart Association/ACC Lifetime risk
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

June 6, 2016

First Posted (ESTIMATE)

June 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00042101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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