Vascular AgingNCT02795624
Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure
An observational study of Vascular Aging and Secondhand Smoking, run by Cedars-Sinai Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Vascular Aging, Secondhand Smoking
- What is being tested?
- Spirometry, Pulse Wave Analysis and Peripheral arterial tonometry
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Flight attendants that are 40 years of age and older, with prior occupation secondhand smoke (SHS) exposure pre- and post- smoking ban.
Who may be able to join
- 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
Who cannot join
- History of Raynaud's syndrome
- Had mastectomy or arm/hand abnormality in which blood pressure cannot be measured on the arm
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Women's Heart Center
Los Angeles, California, 90048
About this study
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.
Read more
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.
Read the detailed 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.
- Conditions
- Vascular Aging, Secondhand Smoking
- Being tested
- Spirometry, Pulse Wave Analysis, Peripheral arterial tonometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryProcedure or surgery
Also called Breathing test
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 AnalysisProcedure or surgery
Also called PWA, Arterial stiffness test
It is a non-invasive assessment of the pulse character
Peripheral arterial tonometryProcedure or surgery
Also called Endothelial function test
It is a non-invasive method to measure endothelial dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Flight attendants | Flight attendants Receives: Procedure: Spirometry; Procedure: Pulse Wave Analysis; Procedure: Peripheral arterial tonometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Dysfunction (RHI)
Reactive hyperemia index (RHI) will be measured by Peripheral Arterial Tonometry, which reflects endothelial dysfunction
Measured: Baseline
Arterial Stiffness (PWV)
During Pulse Wave analysis, pulse wave velocity (PWV) will be measured
Measured: Baseline
Arterial Stiffness (AIx)
During Pulse Wave analysis, augmentation index (AIx) wil be measured
Measured: Baseline
Secondary outcomes (4)
Cardiovascular risk
Framingham 10-year risk
Measured: Baseline
Cardiovascular risk
Reynolds 10-year risk
Measured: Baseline
Cardiovascular risk
American Heart Association/ACC 10-year risk
Measured: Baseline
Cardiovascular risk
American Heart Association/ACC Lifetime risk
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AgingStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Noel Bairey Merz, Cedars-Sinai Medical Center
- Investigators
- C.Noel Bairey Merz, MD, FACC, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795624
- Sponsor's protocol ID
- Pro00042101
- Status last verified
- Aug 2021
- First submitted
- 27 Jan 2016
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Aging in Flight Attendants With Occupational Secondhand Smoke Exposure
- ClinicalTrials.gov ID
- NCT02795624
- Acronym / sponsor ID
- Pro00042101
- Conditions
- Vascular Aging, Secondhand Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Feb 2016
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flight attendants | – | Procedure: Spirometry, Procedure: Pulse Wave Analysis, Procedure: Peripheral arterial tonometryFlight attendants |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Flight attendants that are 40 years of age and older, with prior occupation secondhand smoke (SHS) exposure pre- and post- smoking ban.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- History of Raynaud's syndrome
- Had mastectomy or arm/hand abnormality in which blood pressure cannot be measured on the arm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometryAlso: Breathing testTest 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. | Procedure or surgery | Flight attendants |
| Pulse Wave AnalysisAlso: PWA, Arterial stiffness testIt is a non-invasive assessment of the pulse character | Procedure or surgery | Flight attendants |
| Peripheral arterial tonometryAlso: Endothelial function testIt is a non-invasive method to measure endothelial dysfunction. | Procedure or surgery | Flight attendants |
Primary outcome
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
4 secondary outcomes
Cardiovascular risk
Time frame: Baseline
Cardiovascular risk
Time frame: Baseline
Cardiovascular risk
Time frame: Baseline
Cardiovascular risk
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.Noel Bairey Merz, MD, FACC principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Aging and Secondhand Smoking, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Dysfunction (RHI) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.