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Completed

NCT Number: NCT02795624

Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

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.

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Key information

Conditions

Vascular Aging Secondhand Smoking

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirometry

Procedure

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

Pulse Wave Analysis

Procedure

It is a non-invasive assessment of the pulse character

Other names: PWA, Arterial stiffness test

Peripheral arterial tonometry

Procedure

It is a non-invasive method to measure endothelial dysfunction.

Other names: Endothelial function test

Primary outcomes

  1. Endothelial Dysfunction (RHI)

    Time frame: Baseline

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

  2. Arterial Stiffness (PWV)

    Time frame: Baseline

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

  3. Arterial Stiffness (AIx)

    Time frame: Baseline

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

Secondary outcomes

  1. Cardiovascular risk

    Time frame: Baseline

    Framingham 10-year risk

  2. Cardiovascular risk

    Time frame: Baseline

    Reynolds 10-year risk

  3. Cardiovascular risk

    Time frame: Baseline

    American Heart Association/ACC 10-year risk

  4. Cardiovascular risk

    Time frame: Baseline

    American Heart Association/ACC Lifetime risk

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • University of California, San Francisco

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2016
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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