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Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

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ClinicalTrials.gov Identifier: NCT02795624
Recruitment Status : Suspended (The study sponsor stopped the funding.)
First Posted : June 10, 2016
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center

Brief 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.


Condition or disease Intervention/treatment
Vascular Aging Secondhand Smoking Procedure: Spirometry Procedure: Pulse Wave Analysis Procedure: Peripheral arterial tonometry

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure
Study Start Date : February 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Group/Cohort Intervention/treatment
Flight attendants
Flight attendants
Procedure: Spirometry
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 Name: Breathing test

Procedure: Pulse Wave Analysis
It is a non-invasive assessment of the pulse character
Other Names:
  • PWA
  • Arterial stiffness test

Procedure: Peripheral arterial tonometry
It is a non-invasive method to measure endothelial dysfunction.
Other Name: Endothelial function test




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795624


Locations
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United States, California
Cedars-Sinai Women's Heart Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
University of California, San Francisco
Investigators
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Principal Investigator: C.Noel Bairey Merz, MD, FACC Cedars-Sinai Medical Center

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Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02795624     History of Changes
Other Study ID Numbers: Pro00042101
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes