- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00774514
The Cardiovascular Effects of Nitrogen Dioxide Exposure
April 8, 2009 updated by: University of Edinburgh
Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality.
The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources.
It has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis.
Recent studies using an inline retrofit particle trap to reduce the particulate component of exhaust have shown that filtering particles leads to a reversal of the endothelial dysfunction seen after diesel exhaust exposure, and have even suggested an augmentation of vascular function.
This raises the question of the cardiovascular effects of the gaseous pollutants, the most abundant of which is nitrogen dioxide.
In this study we plan to investigate the cardiovascular effects of nitrogen dioxide exposure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Umeå, Sweden
- Umeå University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male volunteers
Exclusion Criteria:
- Current smokers
- Significant occupational exposure to air pollution
- Regular medication use
- Intercurrent illness
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Air exposure
1 hour exposure to filtered air during intermittent exercise
|
Forearm venous occlusion plethysmography to measure forearm blood flow during intrabrachial infusion of vasodilators Acetylcholine (5-20 mg/min), sodium nitroprusside (2-8 µg/min), bradykinin (100-1000 pmol/min) and verapamil (10-100 µg/min)
Other Names:
|
|
Experimental: NO2 exposure
1 hour exposure to nitrogen dioxide at 4ppm during intermittent exercise
|
Forearm venous occlusion plethysmography to measure forearm blood flow during intrabrachial infusion of vasodilators Acetylcholine (5-20 mg/min), sodium nitroprusside (2-8 µg/min), bradykinin (100-1000 pmol/min) and verapamil (10-100 µg/min)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Forearm blood flow measured by venous occlusion plethysmography in response to intraarterial vasodilators (acetylcholine, sodium nitroprusside, bradykinin and verapamil)
Time Frame: 4-6 hours after exposure
|
4-6 hours after exposure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma t-PA concentrations after infusion of bradykinin
Time Frame: During forearm study
|
During forearm study
|
|
Exhaled nitric oxide
Time Frame: 4-6 hours after exposure
|
4-6 hours after exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anders Blomberg, MD PhD, Umeå University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
October 16, 2008
First Submitted That Met QC Criteria
October 16, 2008
First Posted (Estimate)
October 17, 2008
Study Record Updates
Last Update Posted (Estimate)
April 9, 2009
Last Update Submitted That Met QC Criteria
April 8, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- Dnr 08-113M
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.