Cardiopulmonary Study Effects of Secondhand-Smoke (FAMRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01639235
First received: July 9, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

The investigators are conducting a study to test whether exposure to secondhand tobacco smoke causes negative effects on the subject's health. In particular, the investigators wish to find out whether secondhand tobacco smoke exposure causes heart or lung problems.


Condition
Second Hand Smoke

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Noninvasive Index of the Detrimental Cardiopulmonary Effects of Environmental Tobacco Smoke

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 200
Study Start Date: June 2005
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Detailed Description:

This study aims to ascertain whether standard exercise stress testing can detect subclinical cardiopulmonary disability in subjects with significant exposure to second hand tobacco smoke (SHS). The ultimate goal of this study is to contribute to the understanding of SHS-related illnesses, and to the care of future patients with SHS exposure.

The main hypothesis of this study is that exposure to the secondhand tobacco smoke (SHS) in the confined workspace of commercial aircraft prior to the ban against cigarette smoking is responsible for long-term damage to the lungs of nonsmoking flight attendants. Although only some flight attendants show evidence of this damage on their lung function at rest, the majority of the flight attendants will have abnormal diffusing capacity during exercise as the damage may be too subtle to be detected with lung function measurements at rest. To test these hypotheses, we will compare pre- and post-ban flight attendants to each other and to two groups of age-matched, nonsmoking controls living at sea level stratified on the basis of SHS exposure. The results of our study should permit us to determine whether SHS alone could account for the lung damage in flight attendants, or whether some more complex interaction (involving cabin factors such as ozone, altitude, radiation and SHS) may be involve.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

This is a cross-sectional observational study of cases (flight attendants exposed to secondhand tobacco smoke, SHS) and controls (flight attendants not exposed to SHS).

Criteria

Inclusion Criteria:

  • Pre-ban flight attendants:

    1. Never smoker flight attendants who began working for airlines before the smoking ban on aircrafts went into effect. Never smoker is defined those with history of tobacco use of less than 100 cigarettes in their lifetime.
    2. SHS exposure > 5 years while working with the airlines.
  • Post-ban control flight attendants:

The control patients will be age matched flight attendants without aircraft cabin second hand smoke exposure (those who started flying after the tobacco ban). The purpose of having these control groups is to determine if any differences in cardiopulmonary data is due to SHS exposure or other factors associated with flying.

In addition, we will recruit non-flight attendants volunteers with and without history of SHS exposure from a previously characterized cohort. These subjects will be age-matched control group of never smokers, and must have grown up and spent the majority of their adulthood at sea level and have had no connection with the airline industry.

Exclusion Criteria:

  1. History of clinically overt cardiac disease, including: stable or unstable angina; coronary artery disease (abnormal stress test; cardiac catheterization showing > 70% coronary artery stenosis; history of revascularization; pathologic Q waves on EKG); uncontrolled resting hypertension (SBP > 160/ DBP>95); congestive heart failure (EF < 55%; physical exam findings of CHF; symptomatic pulmonary edema); significant (> mild) valvular heart disease; congenital heart disease.
  2. History of clinically overt pulmonary disease, including: asthma, including childhood; COPD; chronic interstitial lung disease; pulmonary hypertension.
  3. Debilitating chronic illness, including untreated thyroid disease.
  4. Pregnancy.
  5. Abnormalities of baseline examination including: resting hypertension (> 160/95); abnormal cardiopulmonary physical examination; abnormal baseline electrocardiogram (left ventricular hypertrophy; ischemic changes; prior myocardial infarction; arrhythmia other than premature atrial contractions); abnormal baseline echocardiogram (LVEF < 55%, segmental wall motion abnormalities, > mild valvular heart disease).
  6. Physical inability to perform supine bicycle exercise testing, including: paralysis, weakness, amputation, or symptomatic arthritis of the lower extremities; disabling back pain.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639235

Contacts
Contact: Andrea silva 415-412-0872 asilva@medicine.ucsf.edu

Locations
United States, California
University of California, San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94143
Contact: Cecilia Yu    415-412-0872      
Sub-Investigator: Warren Gold, MD         
Sub-Investigator: Mehrdad Arjomandi, M.D.         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Rita Redberg, FACC, MD, MSc University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01639235     History of Changes
Other Study ID Numbers: 10-04549, FAMRI
Study First Received: July 9, 2012
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Characterize the long-term effects of SHS on lung function at rest in pre-ban flight attendants.
Characterize the long-term effects of SHS on lung function during exercise in pre-ban flight attendants.
Determine abnormalities in lung function of flight attendants are associated with SHS in aircraft cabin.

ClinicalTrials.gov processed this record on August 20, 2014