Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

NCT02795624 | Completed

• 1 other identifier: Pro00042101
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Aging; Secondhand Smoking

Outcome Measures

Primary Outcomes (3)

• Endothelial Dysfunction (RHI)

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

  Baseline

• Arterial Stiffness (PWV)

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

  Baseline

• Arterial Stiffness (AIx)

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

  Baseline

Secondary Outcomes (4)

• Cardiovascular risk

  Baseline

• Cardiovascular risk

  Baseline

• Cardiovascular risk

  Baseline

• Cardiovascular risk

  Baseline

Study Arms (1)

Flight attendants

Flight attendants

Procedure: Spirometry; Procedure: Pulse Wave Analysis; Procedure: Peripheral arterial tonometry

Interventions

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.

Also known as: Breathing test

Flight attendants

Pulse Wave Analysis PROCEDURE

It is a non-invasive assessment of the pulse character

Also known as: PWA, Arterial stiffness test

Flight attendants

Peripheral arterial tonometry PROCEDURE

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

Also known as: Endothelial function test

Flight attendants

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Location

Study Officials

• C.Noel Bairey Merz, MD, FACC

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: June 10, 2016
• Study Start: February 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)