CompletedNot Applicable

Cardiovascular Effects of Incremental Diesel Exhaust Inhalation in Middle-Aged Healthy GSTM1 Null Human Volunteers

United States6 participantsStarted 2007-07

Plain-language summary

Purpose: A growing body of epidemiological data suggests an increased risk of cardiovascular events associated with air pollutants. Reactive oxygen species (ROS) have been implicated as a potential mechanism for the adverse effects of air pollutants and genetic polymorphisms of the glutathione-s-transferases (GSTs) have been shown to participate in the antioxidant defenses to air pollutants. This study examined the dose effects of diesel exhaust exposure on the cardiovascular system in healthy middle-aged subjects. Participants: Six healthy 50-75 year-old male and female subjects with GSTM1 null genotype had 3 sequential exposures to the diesel exhausts at concentrations approximately 100 µg/m3, 200 µg/m3, and 300 µg/m3 for 2 hours with a about 2 weeks of interval between exposures.

Who can participate

Age range

50 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 50-75 years old generally healthy male and female. * Normal resting ECG. * Oxygen saturation greater than 94% at the time of physical exam. Exclusion Criteria: * A history of angina, cardiac arrhythmias, and ischemic myocardial infarction or coronary bypass surgery. * Cardiac pacemaker. * Uncontrolled hypertension (\> 150 systolic, \> 90 diastolic). * Neurodegenerative diseases such as Parkinson's and Alzheimer disease. * A history of chronic illnesses such as diabetes, cancer, rheumatologic diseases, immunodeficiency state, known cardiovascular disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma. * History of bleeding diathesis. * Currently taking HMG-CoA reductase inhibitors for hyperlipidemia including lovastatin, pravastatin, simvastatin, and atorvastatin. * Currently taking beta-blockers to control hypertension and/or arrhythmias. * Use of oral anticoagulants. * Participants must refrain from all over-the-counter NSAIDs for a period of two weeks prior to exposure. Low-dose aspirin will be acceptable. Medications not specifically mentioned here may be reviewed by the investigators prior to a participant's inclusion in the study. * Subjects who are currently smoking or have smoking history within 1 year of study (defined as more than one pack of cigarettes in the past year). * Subject is pregnant, attempting to become pregnant or breastfeeding. * No exposure will be conducted within 4 weeks of a …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vascular effects of DE exposure

Timeframe: One hour before and 1 hour after DE exposure

Trial details

NCT IDNCT01548625

SponsorEnvironmental Protection Agency (EPA)

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2008-11

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