Completed

MIDASMyocardial Ischaemia After Exposure to Diesel Exhaust

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What is being tested

CT/PET Myocardial Perfusion Imaging using O-15 water

+ Coronary blood flow measured by doppler echocardiography

+ CT/PET Myocardial Perfusion Imaging using O-15 water

Other
Who is being recruted

Arterial Occlusive Diseases+5

+ Arteriosclerosis

+ Cardiovascular Diseases

From 18 to 60 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-Controlled
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of Edinburgh
Last updated: May 9, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: September 20, 2012

Actual date on which the first participant was enrolled.

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

Principal SponsorUniversity of Edinburgh
Last updated: May 9, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial IschemiaCoronary Artery DiseaseCoronary Disease

Criteria

2 inclusion criteria required to participate
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

14 exclusion criteria prevent from participating
Abnormal 12-lead electrocardiogram

Abnormal exercise stress test

Acute coronary syndrome within past 3 months

Asthma

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Edinburgh / NHS Lothian

Edinburgh, United KingdomOpen University of Edinburgh / NHS Lothian in Google Maps
CompletedOne Study Center