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
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|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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
Procedure: Peripheral arterial tonometry
It is a non-invasive method to measure endothelial dysfunction.
Other Name: Endothelial function test
- Endothelial Dysfunction (RHI) [ Time Frame: Baseline ]Reactive hyperemia index (RHI) will be measured by Peripheral Arterial Tonometry, which reflects endothelial dysfunction
- Arterial Stiffness (PWV) [ Time Frame: Baseline ]During Pulse Wave analysis, pulse wave velocity (PWV) will be measured
- Arterial Stiffness (AIx) [ Time Frame: Baseline ]During Pulse Wave analysis, augmentation index (AIx) wil be measured
- Cardiovascular risk [ Time Frame: Baseline ]Framingham 10-year risk
- Cardiovascular risk [ Time Frame: Baseline ]Reynolds 10-year risk
- Cardiovascular risk [ Time Frame: Baseline ]American Heart Association/ACC 10-year risk
- Cardiovascular risk [ Time Frame: Baseline ]American Heart Association/ACC Lifetime risk
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
|United States, California|
|Cedars-Sinai Women's Heart Center|
|Los Angeles, California, United States, 90048|
|Principal Investigator:||C.Noel Bairey Merz, MD, FACC||Cedars-Sinai Medical Center|