We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Ischaemia After Exposure to Diesel Exhaust (MIDAS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Edinburgh.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01661582
First Posted: August 9, 2012
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute for Public Health and the Environment (RIVM)
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh
August 7, 2012
August 9, 2012
December 3, 2014
October 2012
February 2015   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01661582 on ClinicalTrials.gov Archive Site
  • Coronary flow reserve determined using doppler echocardiography [ Time Frame: 1 hour following exposure ]
    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 [ Time Frame: Before, 2 and 24 hours following exposure ]
    Blood samples will be obtained for measurement of cardiac troponin-I
  • ST segment deviation on continuous 12-lead electrocardiography [ Time Frame: During and for the 24 hours aftet exposure ]
    A 12-lead electrocardiogram will be continuously recorded using Holter ECG monitor
Same as current
Not Provided
Not Provided
 
Myocardial Ischaemia After Exposure to Diesel Exhaust
Myocardial Ischaemia After Exposure to Diesel Exhaust

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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Coronary Heart Disease
  • Other: CT/PET Myocardial Perfusion Imaging using O-15 water
  • Other: Coronary blood flow measured by doppler echocardiography
  • Placebo Comparator: Filtered Air Exposure
    Subjects will be exposed to filtered air for 1 hour during intermittent exercise in a purpose-built exposure facility
    Interventions:
    • Other: CT/PET Myocardial Perfusion Imaging using O-15 water
    • Other: Coronary blood flow measured by doppler echocardiography
  • Experimental: 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
    Interventions:
    • Other: CT/PET Myocardial Perfusion Imaging using O-15 water
    • Other: Coronary blood flow measured by doppler echocardiography

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
August 2015
February 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01661582
MIDAS
No
Not Provided
Not Provided
University of Edinburgh
University of Edinburgh
  • National Institute for Public Health and the Environment (RIVM)
  • British Heart Foundation
Study Chair: David E Newby, PhD FRCP University of Edinburgh
Principal Investigator: Jeremy P Langrish, MB BCh MRCP University of Edinburgh
University of Edinburgh
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP