Myocardial Ischaemia After Exposure to Diesel Exhaust

Coronary Heart Disease Clinical Trial

— MIDAS  

Official title:

Myocardial Ischaemia After Exposure to Diesel Exhaust

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01661582
• Other study ID #: MIDAS
• Status: Completed
• Phase: N/A
• Start date: September 20, 2012
• Est. completion date: February 13, 2015

Study information

• Verified date: May 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 13, 2015
• Est. primary completion date: February 13, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

Other:
• CT/PET Myocardial Perfusion Imaging using O-15 water

• Coronary blood flow measured by doppler echocardiography

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh / NHS Lothian	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation, National Institute for Public Health and the Environment (RIVM)

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediately following exposure
Secondary	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	1 hour following exposure
Secondary	Ultra-sensitive cardiac troponin-I	Blood samples will be obtained for measurement of cardiac troponin-I	Before, 2 and 24 hours following exposure
Secondary	ST segment deviation on continuous 12-lead electrocardiography	A 12-lead electrocardiogram will be continuously recorded using Holter ECG monitor	During and for the 24 hours aftet exposure