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Completed

NCT Number: NCT01661582

Myocardial Ischaemia After Exposure to Diesel Exhaust

Exposure to particulate air pollution is associated with increases in cardiovascular mortality and morbidity. The pathophysiological mechanisms underlying this observation are emerging, and exposure to particulate air pollution has been shown to result in increases in blood pressure and arterial tone, impaired vascular function and an increased tendency for blood to clot as well as an increase in atherosclerotic plaque burden. Recent evidence from panel studies and controlled exposure studies have suggested an increase in myocardial ischaemia (a reduction in blood flow to the heart) following exposure. In this study we aim to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust (as a model of urban air pollution) using CT/PET myocardial perfusion imaging in male patients with stable coronary disease and healthy male controls. We hypothesize that following exposure to dilute diesel exhaust:

1. Myocardial blood flow will be reduced 2. Coronary flow reserve will be impaired 3. The magnitude of impairment will be higher in patients with coronary disease as compared to healthy controls

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Key information

Conditions

Coronary Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh / NHS Lothian

Edinburgh, EH16 4SB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers will be taking no regular medication, have a normal electrocardiogram and exercise stress test
  • Patients with a previous history of myocardial infarction or successful coronary revascularization (PTCA or coronary artery bypass grafting) but without symptoms of angina pectoris will be recruited

Exclusion criteria

  • Healthy volunteers:
  • Regular medication
  • Abnormal 12-lead electrocardiogram
  • Abnormal exercise stress test
  • Patients with coronary disease
  • Acute coronary syndrome within past 3 months
  • Impaired left ventricular function
  • Significant valvular heart disease
  • Left ventricular hypertrophy
  • Resting conduction defect
  • Digoxin use
  • Renal impairment (eGFR <60 mL/min)
  • Hepatic impairment
  • Asthma

Treatment and study plan

CT/PET Myocardial Perfusion Imaging using O-15 water

Other

Coronary blood flow measured by doppler echocardiography

Other

Primary outcomes

  1. Myocardial blood flow and coronary flow reserve measured by CT/PET O-15 imaging

    Time frame: Immediately following exposure

    Myocardial blood flow will be measured at rest and at peak adenosine stress using CT/PET O-15 myocardial perfusion imaging immediately following exposure to diesel exhaust and filtered air

Secondary outcomes

  1. Coronary flow reserve determined using doppler echocardiography

    Time frame: 1 hour following exposure

    Coronary blood flow will be determined in the left anterior descending coronary artery using doppler echocardiography at rest and at peak adenosine stress 1 hour following exposure to diesel exhaust and filtered air

  2. Ultra-sensitive cardiac troponin-I

    Time frame: Before, 2 and 24 hours following exposure

    Blood samples will be obtained for measurement of cardiac troponin-I

  3. ST segment deviation on continuous 12-lead electrocardiography

    Time frame: During and for the 24 hours aftet exposure

    A 12-lead electrocardiogram will be continuously recorded using Holter ECG monitor

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation
  • National Institute for Public Health and the Environment (RIVM)

Registry information

Acronym: MIDAS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 9, 2012
Registry last updated
May 9, 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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