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The Cardiovascular Effects of Nitrogen Dioxide Exposure

This study has been completed.
Sponsor:
Collaborator:
Umeå University
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00774514
First received: October 16, 2008
Last updated: April 8, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention
Endothelial Dysfunction
 Procedure: Forearm Vascular Study

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Cardiovascular Effects of Nitrogen Dioxide Exposure

Resource links provided by NLM:

MedlinePlus related topics: Air Pollution
U.S. FDA Resources

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma t-PA concentrations after infusion of bradykinin [ Time Frame: During forearm study ] [ Designated as safety issue: No ]
  • Exhaled nitric oxide [ Time Frame: 4-6 hours after exposure ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: October 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Air exposure
1 hour exposure to filtered air during intermittent exercise
 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)
Other Names:
  • ACh
  • SNP
  • BK
Experimental: NO2 exposure
1 hour exposure to nitrogen dioxide at 4ppm during intermittent exercise
 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)
Other Names:
  • ACh
  • SNP
  • BK

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Current smokers
  • Significant occupational exposure to air pollution
  • Regular medication use
  • Intercurrent illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774514

Locations
Sweden
Umeå University
Umeå, Sweden
Sponsors and Collaborators
University of Edinburgh
Umeå University
Investigators
Principal Investigator: Thomas Sandström, MD PhD Umeå University
Principal Investigator: Anders Blomberg, MD PhD Umeå University
  More Information

No publications provided

Responsible Party: Dr Anders Blomberg, Umeå University
ClinicalTrials.gov Identifier: NCT00774514     History of Changes
Other Study ID Numbers: Dnr 08-113M
Study First Received: October 16, 2008
Last Updated: April 8, 2009
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Edinburgh:
Air Pollution
Nitrogen Dioxide
NO2
Endothelial dysfunction

ClinicalTrials.gov processed this record on May 23, 2013