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The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

This study has been completed.
Sponsor:
Collaborator:
Umeå University
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00745446
First received: September 2, 2008
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation


Condition Intervention
Heart Disease
Procedure: Forearm Venous Occlusion Plethysmography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Forearm blood flow in response to infused intra-arterial vasodilators [ Time Frame: 6 hours post-exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial stiffness measured by applanation tonometry [ Time Frame: In the 1 hour following exposure ] [ Designated as safety issue: No ]
  • Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow [ Time Frame: 2 hours after the exposure ] [ Designated as safety issue: No ]
  • Exhaled nitric oxide - a marker of pulmonary inflammation [ Time Frame: 1 hour & 6 hours after exposure ] [ Designated as safety issue: No ]
  • Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin [ Time Frame: 6 hours after exposure ] [ Designated as safety issue: No ]
  • Biochemical markers of systemic inflammation [ Time Frame: Baseline, 2, 6 & 24 hours ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1 hour exposure to filtered air
Procedure: Forearm Venous Occlusion Plethysmography
Forearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery
Experimental: 2
1 hour exposure to diesel exhaust (300mcg/m3)
Procedure: Forearm Venous Occlusion Plethysmography
Forearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery
Experimental: 3
1 hour exposure to filtered diesel exhaust
Procedure: Forearm Venous Occlusion Plethysmography
Forearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery

Detailed Description:

18 subjects healthy male volunteers will be recruited at Umeå University. In a randomised, double blind 3 way crossover trial, subjects will be exposed to filtered air, diesel exhaust (300mcg/m3) or filtered diesel exhaust for 1 hour during intermittent exercise.

2 hours following the exposure, thrombogenicity will be assessed using the Badimon chamber - an ex-vivo model of thrombosis formed under constant flow conditions.

Forearm blood flow in response to infused intra-brachial vasodilators will be measured using venous occlusion plethysmography 6 hours after the exposure.

Arterial stiffness will be measured using peripheral arterial applanation tonometry in the hour post-exposure.

Blood samples will be collected at timepoints over the 24 hours after exposure.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers

Exclusion Criteria:

  • Intercurrent illness
  • Smoking
  • Significant occupational exposure to air pollution
  • Regular medication usage
  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: NCT00745446

Locations
Sweden
Umeå University
Umeå, Västerbottens, Sweden, SE-901 87
Sponsors and Collaborators
University of Edinburgh
Umeå University
Investigators
Principal Investigator: Anders Blomberg, MD Umeå University
  More Information

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Anders Blomberg, Umeå University
ClinicalTrials.gov Identifier: NCT00745446     History of Changes
Other Study ID Numbers: VOLVO 3ARM
Study First Received: September 2, 2008
Last Updated: September 4, 2008
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University of Edinburgh:
Air pollution
Diesel exhaust
Endothelial function
Vascular function
Particle trap
Thrombosis
effects
inhalation

Additional relevant MeSH terms:
Heart Diseases
Respiratory Aspiration
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014