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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00775099
Other study ID # 05/S1103/46
Secondary ID
Status Completed
Phase N/A
First received October 16, 2008
Last updated October 16, 2008
Start date September 2005
Est. completion date March 2006

Study information

Verified date October 2008
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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 10µm (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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2006
Est. primary completion date March 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Forearm Vascular Study
Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 mg/min).
Badimon Chamber
Ex-vivo assessment of thrombus formation using Badimon Chamber

Locations

Country Name City State
United Kingdom University of Edinburgh Edinburgh

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh National Institute for Public Health and the Environment (RIVM)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Forearm blood flow measured by forearm venous occlusion plethysmography in response to infused vasodilators 6-8 hours after exposure No
Secondary Ex-vivo thrombus formation assessed using the Badimon chamber 6 hours after exposure No
Secondary Arterial stiffness measured by radial artery tonometry Before and after exposure No
Secondary Heart rate and heart rate variability measured with 3 lead Holter electrographic monitors During and for 24 hours after exposure No
Secondary Blood pressure During and after exposure and during forearm study No
Secondary Plasma t-PA and PAI concentrations following infusion of bradykinin During forearm study No
Secondary Plasma inflammatory markers IL-6, TNF-alpha, IL-1 and hsCRP Before and after exposure No
Secondary Platelet monocyte binding as measured by flow cytometry After the exposure No
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