Myocardial Ischaemia After Exposure to Diesel Exhaust

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-20

Study Completion Date

2015-02-13

Brief Summary

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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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Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Filtered Air Exposure

Subjects will be exposed to filtered air for 1 hour during intermittent exercise in a purpose-built exposure facility

Group Type PLACEBO_COMPARATOR

CT/PET Myocardial Perfusion Imaging using O-15 water

Intervention Type OTHER

Coronary blood flow measured by doppler echocardiography

Intervention Type OTHER

Dilute Diesel Exhaust Exposure

Subjects will be exposed to dilute diesel exhaust (\~300 mcg/m3) for 1 hour during intermittent exercise in a purpose-built exposure facility

Group Type EXPERIMENTAL

CT/PET Myocardial Perfusion Imaging using O-15 water

Intervention Type OTHER

Coronary blood flow measured by doppler echocardiography

Intervention Type OTHER

Interventions

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CT/PET Myocardial Perfusion Imaging using O-15 water

Intervention Type OTHER

Coronary blood flow measured by doppler echocardiography

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes