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Completed

NCT Number: NCT00745446

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

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

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Key information

Conditions

Heart Disease Cardiovascular Diseases Embolism and Thrombosis Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Thrombosis Vascular Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, Västerbottens, SE-901 87, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers

Exclusion criteria

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

Treatment and study plan

Forearm Venous Occlusion Plethysmography

Procedure

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

Primary outcomes

  1. Forearm blood flow in response to infused intra-arterial vasodilators

    Time frame: 6 hours post-exposure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Umeå University

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 3, 2008
Registry last updated
Sep 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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