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NCT02795624 · ClinicalTrials.gov registry record
Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure
A clinical trial, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- 300
- Enrollment target
NCT02795624: Completed study, sponsored by Cedars-Sinai Medical Center.
NCT02795624 is a clinical trial that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02795624 has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study 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 increa
Primary Outcome
Reactive hyperemia index (RHI) will be measured by Peripheral Arterial Tonometry, which reflects endothelial dysfunction
Interventions
- PROCEDURE Spirometry
- PROCEDURE Pulse Wave Analysis
- PROCEDURE Peripheral arterial tonometry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2016-02 |
| Est. Completion | 2021-08 |
What the finished NCT02795624 record still lists
NCT02795624 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Spirometry is the first listed.
NCT02795624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02795624 about?
NCT02795624 is a clinical study titled "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 case...
What is the current status of trial NCT02795624?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2016-02. Estimated completion is 2021-08.
What interventions are being tested in trial NCT02795624?
The interventions under investigation include: Spirometry (PROCEDURE), Pulse Wave Analysis (PROCEDURE), Peripheral arterial tonometry (PROCEDURE).
Who is sponsoring clinical trial NCT02795624?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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