Coronary Heart DiseaseMIDASNCT01661582
Myocardial Ischaemia After Exposure to Diesel Exhaust
A study testing CT/PET Myocardial Perfusion Imaging using O-15 water and Coronary blood flow measured by doppler echocardiography in people with Coronary Heart Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- CT/PET Myocardial Perfusion Imaging using O-15 water and Coronary blood flow measured by doppler echocardiography
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Sep 2012to 13 Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Healthy volunteers:
- Regular medication
- Abnormal 12-lead electrocardiogram
- Abnormal exercise stress test
- Patients with coronary disease
- Acute coronary syndrome within past 3 months
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh / NHS Lothian
Edinburgh, EH16 4SB
About this study
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
- Conditions
- Coronary Heart Disease
- Being tested
- CT/PET Myocardial Perfusion Imaging using O-15 water, Coronary blood flow measured by doppler echocardiography
- Keywords
- Air Pollution, Myocardial Ischaemia, Coronary Blood Flow, Diesel Exhaust, Troponin, Electrocardiography
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT/PET Myocardial Perfusion Imaging using O-15 waterOther
Coronary blood flow measured by doppler echocardiographyOther
| Study group | Role | What they receive |
|---|---|---|
| Filtered Air Exposure | Placebo comparator | Subjects will be exposed to filtered air for 1 hour during intermittent exercise in a purpose-built exposure facility Receives: Other: CT/PET Myocardial Perfusion Imaging using O-15 water; Other: Coronary blood flow measured by doppler echocardiography |
| Dilute Diesel Exhaust Exposure | Experimental | Subjects will be exposed to dilute diesel exhaust (~300 mcg/m3) for 1 hour during intermittent exercise in a purpose-built exposure facility Receives: Other: CT/PET Myocardial Perfusion Imaging using O-15 water; Other: Coronary blood flow measured by doppler echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blood flow and coronary flow reserve measured by CT/PET O-15 imaging
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
Measured: Immediately following exposure
Secondary outcomes (3)
Coronary flow reserve determined using doppler echocardiography
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
Measured: 1 hour following exposure
Ultra-sensitive cardiac troponin-I
Blood samples will be obtained for measurement of cardiac troponin-I
Measured: Before, 2 and 24 hours following exposure
ST segment deviation on continuous 12-lead electrocardiography
A 12-lead electrocardiogram will be continuously recorded using Holter ECG monitor
Measured: During and for the 24 hours aftet exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start20 Sep 2012
- Primary completion13 Feb 2015
- Study completion13 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- David E Newby, PhD FRCP, Study chair, University of EdinburghJeremy P Langrish, MB BCh MRCP, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661582
- Sponsor's protocol ID
- MIDAS
- Acronym
- MIDAS
- Status last verified
- May 2024
- First submitted
- 7 Aug 2012
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Mills NL, Tornqvist H, Gonzalez MC, Vink E, Robinson SD, Soderberg S, Boon NA, Donaldson K, Sandstrom T, Blomberg A, Newby DE. Ischemic and thrombotic effects of dilute diesel-exhaust inhalation in men with coronary heart disease. N Engl J Med. 2007 Sep 13;357(11):1075-82. doi: 10.1056/NEJMoa066314.
PubMed 17855668Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.
PubMed 24667535
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Ischaemia After Exposure to Diesel Exhaust
- ClinicalTrials.gov ID
- NCT01661582
- Acronym / sponsor ID
- MIDAS / MIDAS
- Conditions
- Coronary Heart Disease
- Keywords
- Air Pollution, Myocardial Ischaemia, Coronary Blood Flow, Diesel Exhaust, Troponin, Electrocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- National Institute for Public Health and the Environment (RIVM), British Heart Foundation
- Study start
- 20 Sep 2012 (actual)
- Primary completion
- 13 Feb 2015 (actual)
- Study completion
- 13 Feb 2015 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filtered Air Exposure | Placebo comparator | Other: CT/PET Myocardial Perfusion Imaging using O-15 water, Other: Coronary blood flow measured by doppler echocardiographySubjects will be exposed to filtered air for 1 hour during intermittent exercise in a purpose-built exposure facility |
| Dilute Diesel Exhaust Exposure | Experimental | Other: CT/PET Myocardial Perfusion Imaging using O-15 water, Other: Coronary blood flow measured by doppler echocardiographySubjects will be exposed to dilute diesel exhaust (~300 mcg/m3) for 1 hour during intermittent exercise in a purpose-built exposure facility |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- Healthy volunteers:
- Regular medication
- Abnormal 12-lead electrocardiogram
- Abnormal exercise stress test
- Patients with coronary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT/PET Myocardial Perfusion Imaging using O-15 water | Other | Dilute Diesel Exhaust Exposure, Filtered Air Exposure |
| Coronary blood flow measured by doppler echocardiography | Other | Dilute Diesel Exhaust Exposure, Filtered Air Exposure |
Primary outcome
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
3 secondary outcomes
Coronary flow reserve determined using doppler echocardiography
Time frame: 1 hour following exposure
Ultra-sensitive cardiac troponin-I
Time frame: Before, 2 and 24 hours following exposure
ST segment deviation on continuous 12-lead electrocardiography
Time frame: During and for the 24 hours aftet exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 17855668Mills NL, Tornqvist H, Gonzalez MC, Vink E, Robinson SD, Soderberg S, Boon NA, Donaldson K, Sandstrom T, Blomberg A, Newby DE. Ischemic and thrombotic effects of dilute diesel-exhaust inhalation in men with coronary heart disease. N Engl J Med. 2007 Sep 13;357(11):1075-82. doi: 10.1056/NEJMoa066314.
- Derived from this study: PubMed 24667535Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Newby, PhD FRCP study chair
University of Edinburgh
Jeremy P Langrish, MB BCh MRCP principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT/PET Myocardial Perfusion Imaging using O-15 water and Coronary blood flow measured by doppler echocardiography in people with Coronary Heart Disease, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial blood flow and coronary flow reserve measured by CT/PET O-15 imaging (time frame: Immediately following exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.