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

• ClinicalTrials.gov Identifier: NCT00745446
• Recruitment Status: Completed
• First Posted: September 3, 2008
• Last Update Posted: September 5, 2008
• Sponsor: University of Edinburgh
• Collaborator: Umeå University
• Information provided by: University of Edinburgh

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Heart Disease	Procedure: Forearm Venous Occlusion Plethysmography	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation
• Study Start Date: September 2007
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Forearm blood flow in response to infused intra-arterial vasodilators [ Time Frame: 6 hours post-exposure ]

Secondary Outcome Measures :

1. Arterial stiffness measured by applanation tonometry [ Time Frame: In the 1 hour following exposure ]
2. Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow [ Time Frame: 2 hours after the exposure ]
3. Exhaled nitric oxide - a marker of pulmonary inflammation [ Time Frame: 1 hour & 6 hours after exposure ]
4. Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin [ Time Frame: 6 hours after exposure ]
5. Biochemical markers of systemic inflammation [ Time Frame: Baseline, 2, 6 & 24 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lucking AJ, Lundbäck M, Barath SL, Mills NL, Sidhu MK, Langrish JP, Boon NA, Pourazar J, Badimon JJ, Gerlofs-Nijland ME, Cassee FR, Boman C, Donaldson K, Sandstrom T, Newby DE, Blomberg A. Particle traps prevent adverse vascular and prothrombotic effects of diesel engine exhaust inhalation in men. Circulation. 2011 Apr 26;123(16):1721-8. doi: 10.1161/CIRCULATIONAHA.110.987263. Epub 2011 Apr 11.

• Responsible Party: Dr Anders Blomberg, Umeå University
• ClinicalTrials.gov Identifier: NCT00745446
• Other Study ID Numbers: VOLVO 3ARM
• First Posted: September 3, 2008
• Last Update Posted: September 5, 2008
• Last Verified: September 2008

Keywords provided by University of Edinburgh:

Air pollution; Diesel exhaust; Endothelial function; Vascular function; Particle trap; Thrombosis; effects; inhalation

Additional relevant MeSH terms:

Respiratory Aspiration; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes