The Cardiovascular Effects of Nitrogen Dioxide Exposure

Endothelial Dysfunction Clinical Trial

Official title:

The Cardiovascular Effects of Nitrogen Dioxide Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774514
• Other study ID #: Dnr 08-113M
• Status: Completed
• Phase: N/A
• First received: October 16, 2008
• Last updated: April 8, 2009
• Start date: October 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2009
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Healthy male volunteers

Exclusion Criteria:

• Current smokers

• Significant occupational exposure to air pollution

• Regular medication use

• Intercurrent illness

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Procedure:
• Forearm Vascular Study
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)

Locations

Country	Name	City	State
Sweden	Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow measured by venous occlusion plethysmography in response to intraarterial vasodilators (acetylcholine, sodium nitroprusside, bradykinin and verapamil)		4-6 hours after exposure	No
Secondary	Plasma t-PA concentrations after infusion of bradykinin		During forearm study	No
Secondary	Exhaled nitric oxide		4-6 hours after exposure	No