The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation - Full Text View

Sponsors and Collaborators:	University of Edinburgh Umeå University
Information provided by:	University of Edinburgh
ClinicalTrials.gov Identifier:	NCT00745446

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:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment
Official Title:	The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

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
1: Experimental 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
2: Experimental 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
3: Experimental 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745446

Locations

Sweden, Västerbottens
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

Responsible Party:	Umeå University ( Dr Anders Blomberg )
Study ID Numbers:	VOLVO 3ARM
Study First Received:	September 2, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00745446 History of Changes
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

Study placed in the following topic categories:

Verapamil
Heart Diseases
Bradykinin
Diltiazem

Nitroprusside
Acetylcholine
Thrombosis

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009