- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90048
- Cedars-Sinai Women's Heart Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Flight attendants
|
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:
It is a non-invasive assessment of the pulse character
Other Names:
It is a non-invasive method to measure endothelial dysfunction.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endothelial Dysfunction (RHI)
Time Frame: Baseline
|
Reactive hyperemia index (RHI) will be measured by Peripheral Arterial Tonometry, which reflects endothelial dysfunction
|
Baseline
|
|
Arterial Stiffness (PWV)
Time Frame: Baseline
|
During Pulse Wave analysis, pulse wave velocity (PWV) will be measured
|
Baseline
|
|
Arterial Stiffness (AIx)
Time Frame: Baseline
|
During Pulse Wave analysis, augmentation index (AIx) wil be measured
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular risk
Time Frame: Baseline
|
Framingham 10-year risk
|
Baseline
|
|
Cardiovascular risk
Time Frame: Baseline
|
Reynolds 10-year risk
|
Baseline
|
|
Cardiovascular risk
Time Frame: Baseline
|
American Heart Association/ACC 10-year risk
|
Baseline
|
|
Cardiovascular risk
Time Frame: Baseline
|
American Heart Association/ACC Lifetime risk
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00042101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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