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Completed

NCT Number: NCT00745693

The Effects of Diesel Exhaust Inhalation on Vascular Function - the Role of Endothelin

The purpose of this study is to identify the role of endothelin 1 (a natural vasoconstrictor) in the adverse vascular effects demonstrated after exposure to air pollution

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia 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

Air pollution is a major problem, and can be linked to around 5% of all deaths worldwide each year. There are strong associations between air pollution exposure and heart disease but we do not yet understand how these harmful effects are mediated. Understanding this mechanism is likely to have a major impact on the way we treat patients with heart disease and have the potential to shape future environmental health policy. The upregulation of Endothelin-1 provides a plausible mechanism for these harmful effects, and we plan to investigate this in more depth in the human forearm following exposure to diesel exhaust.

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

  • Use of regular medication
  • Cigarette smoking
  • Significant occupational exposure to air pollution
  • Intercurrent illness

Treatment and study plan

Endothelin-1

Drug

Intra-arterial infusion of Endothelin-1 at 5pmol/min for 1 hour during venous occlusion plethysmography

Other names: ET-1, American Peptides - 88-1-10 (ET-1)

BQ-123 and BQ-788

Drug

1 hour intra-arterial infusion of BQ-123 at 10nmol/min followed by co-infusion of BQ-788 at 1nmol/min for a further hour during forearm venous occlusion plethysmography

Other names: American Peptides - 88-2-10 (BQ-123), American Peptides - 88-2-55 (BQ-788)

Primary outcomes

  1. Change in forearm blood flow following infusion of endothelin-1 or the endothelin receptor antagonists BQ-123 & BQ-788

    Time frame: 2 hours after exposure

Secondary outcomes

  1. 24 hour mean blood pressure (ambulatory monitoring)

    Time frame: 24 hours following the exposure

  2. Systemic endothelin-1 and big endothelin-1 concentrations

    Time frame: At baseline, and immediately, 1, 2, 3, 4, 6 and 24 hours after exposure

  3. Changes in arterial stiffness (pulse-wave velocity)

    Time frame: During and for the 1 hour after the exposure

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Umeå University

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 3, 2008
Registry last updated
May 17, 2024

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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