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Combustion Derived Air Pollution and Vascular Function

Information source: University of Edinburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endothelial Dysfunction

Intervention: Forearm Vascular Study (Procedure); Badimon Chamber (Procedure)

Phase: N/A

Status: Completed

Sponsored by: University of Edinburgh

Official(s) and/or principal investigator(s):
Nicholas L Mills, MB BCh MRCP, Principal Investigator, Affiliation: University of Edinburgh

Summary

Air pollution is a major cause of cardiovascular morbidity and mortality. The components of air pollution responsible and the mechanisms through which they might mediate these harmful effects remain only partially understood. The link between cardiovascular disease and air pollution is strongest for fine particulate matter. Fine particulate matter (PM) is produced from the combustion of fossil fuels with the most significant threat thought to be posed by small particles less than 10m (PM 10) which can be inhaled into the lungs. We propose to identify the precise component of diesel exhaust that mediates the adverse cardiovascular effects using a carbon particle generator, and a particle concentrator. The aim of this study proposal is to assess the vascular effects of different types and components of air pollution in healthy subjects. We intend to test the hypotheses that: 1. Combustion derived nanoparticulate causes an acute impairment of endothelial vasomotor and fibrinolytic function in healthy volunteers. 2. Exposure to combustion derived air pollution is associated with increased thrombus formation.

Clinical Details

Official title: The Effects of Combustion-Derived Air Pollution on Vascular Vasomotor and Fibrinolytic Function in Healthy Volunteers (Diesel Exposure)

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Forearm blood flow measured by forearm venous occlusion plethysmography in response to infused vasodilators

Secondary outcome:

Ex-vivo thrombus formation assessed using the Badimon chamber

Arterial stiffness measured by radial artery tonometry

Heart rate and heart rate variability measured with 3 lead Holter electrographic monitors

Blood pressure

Plasma t-PA and PAI concentrations following infusion of bradykinin

Plasma inflammatory markers IL-6, TNF-alpha, IL-1 and hsCRP

Platelet monocyte binding as measured by flow cytometry

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy volunteers

Exclusion Criteria:

- Current smokers

- Significant occupational exposure to air pollution

- History of lung disease

- Women of child-bearing potential

- Malignant arrhythmias

- Renal or hepatic failure

- Significant co-morbidity

- Systolic blood pressure >190 or <100 mmHg

- Previous history of blood dyscrasia

- Unable to tolerate the supine position

- Lack of informed consent

- Blood donation within last 3 months

Locations and Contacts

University of Edinburgh, Edinburgh EH16 4SB, United Kingdom
Additional Information

Related publications:

Mills NL, Törnqvist H, Robinson SD, Gonzalez M, Darnley K, MacNee W, Boon NA, Donaldson K, Blomberg A, Sandstrom T, Newby DE. Diesel exhaust inhalation causes vascular dysfunction and impaired endogenous fibrinolysis. Circulation. 2005 Dec 20;112(25):3930-6.

Starting date: September 2005
Last updated: October 16, 2008

Page last updated: August 23, 2015

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