Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

Vascular Aging Clinical Trial

Official title:

Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02795624
• Other study ID #: Pro00042101
• Status: Completed
• Start date: February 2016
• Est. completion date: August 2021

Study information

• Verified date: August 2021
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Secondhand Smoking
• Vascular Aging

Intervention

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.
• Pulse Wave Analysis
It is a non-invasive assessment of the pulse character
• Peripheral arterial tonometry
It is a non-invasive method to measure endothelial dysfunction.

Locations

Country	Name	City	State
United States	Cedars-Sinai Women's Heart Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Dysfunction (RHI)	Reactive hyperemia index (RHI) will be measured by Peripheral Arterial Tonometry, which reflects endothelial dysfunction	Baseline
Primary	Arterial Stiffness (PWV)	During Pulse Wave analysis, pulse wave velocity (PWV) will be measured	Baseline
Primary	Arterial Stiffness (AIx)	During Pulse Wave analysis, augmentation index (AIx) wil be measured	Baseline
Secondary	Cardiovascular risk	Framingham 10-year risk	Baseline
Secondary	Cardiovascular risk	Reynolds 10-year risk	Baseline
Secondary	Cardiovascular risk	American Heart Association/ACC 10-year risk	Baseline
Secondary	Cardiovascular risk	American Heart Association/ACC Lifetime risk	Baseline