Myocardial Ischaemia After Exposure to Diesel Exhaust (MIDAS)
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CT/PET Myocardial Perfusion Imaging using O-15 water
Coronary blood flow measured by doppler echocardiography
Sponsored by
About this trial
This is an interventional basic science trial for Coronary Heart Disease focused on measuring Air Pollution, Myocardial Ischaemia, Coronary Blood Flow, Diesel Exhaust, Troponin, Electrocardiography
Eligibility Criteria
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
Sites / Locations
- University of Edinburgh / NHS LothianRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Filtered Air Exposure
Dilute Diesel Exhaust Exposure
Arm Description
Subjects will be exposed to filtered air for 1 hour during intermittent exercise in a purpose-built exposure facility
Subjects will be exposed to dilute diesel exhaust (~300 mcg/m3) for 1 hour during intermittent exercise in a purpose-built exposure facility
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Ultra-sensitive cardiac troponin-I
Blood samples will be obtained for measurement of cardiac troponin-I
ST segment deviation on continuous 12-lead electrocardiography
A 12-lead electrocardiogram will be continuously recorded using Holter ECG monitor
Full Information
NCT ID
NCT01661582
First Posted
August 7, 2012
Last Updated
December 2, 2014
Sponsor
University of Edinburgh
Collaborators
National Institute for Public Health and the Environment (RIVM), British Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01661582
Brief Title
Myocardial Ischaemia After Exposure to Diesel Exhaust
Acronym
MIDAS
Official Title
Myocardial Ischaemia After Exposure to Diesel Exhaust
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
National Institute for Public Health and the Environment (RIVM), British Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Air Pollution, Myocardial Ischaemia, Coronary Blood Flow, Diesel Exhaust, Troponin, Electrocardiography
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Filtered Air Exposure
Arm Type
Placebo Comparator
Arm Description
Subjects will be exposed to filtered air for 1 hour during intermittent exercise in a purpose-built exposure facility
Arm Title
Dilute Diesel Exhaust Exposure
Arm Type
Experimental
Arm Description
Subjects will be exposed to dilute diesel exhaust (~300 mcg/m3) for 1 hour during intermittent exercise in a purpose-built exposure facility
Intervention Type
Other
Intervention Name(s)
CT/PET Myocardial Perfusion Imaging using O-15 water
Intervention Type
Other
Intervention Name(s)
Coronary blood flow measured by doppler echocardiography
Primary Outcome Measure Information:
Title
Myocardial blood flow and coronary flow reserve measured by CT/PET O-15 imaging
Description
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
Time Frame
Immediately following exposure
Secondary Outcome Measure Information:
Title
Coronary flow reserve determined using doppler echocardiography
Description
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
Time Frame
1 hour following exposure
Title
Ultra-sensitive cardiac troponin-I
Description
Blood samples will be obtained for measurement of cardiac troponin-I
Time Frame
Before, 2 and 24 hours following exposure
Title
ST segment deviation on continuous 12-lead electrocardiography
Description
A 12-lead electrocardiogram will be continuously recorded using Holter ECG monitor
Time Frame
During and for the 24 hours aftet exposure
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy P Langrish, MB BCh MRCP
Phone
+441312426428
Email
jeremy.langrish@ed.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Newby, PhD FRCP
Organizational Affiliation
University of Edinburgh
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeremy P Langrish, MB BCh MRCP
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Edinburgh / NHS Lothian
City
Edinburgh
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy P Langrish, MB BCh MRCP
First Name & Middle Initial & Last Name & Degree
Nicholas L Mills, PhD MRCP
First Name & Middle Initial & Last Name & Degree
Anoop Shah, MB BCh MRCP
12. IPD Sharing Statement
Citations:
PubMed Identifier
17855668
Citation
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.
Results Reference
background
PubMed Identifier
24667535
Citation
Langrish 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.
Results Reference
derived
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Myocardial Ischaemia After Exposure to Diesel Exhaust
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