Myocardial Ischaemia After Exposure to Diesel Exhaust (MIDAS)

May 8, 2024 updated by: University of Edinburgh

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH16 4SB
        • University of Edinburgh / NHS Lothian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Filtered Air Exposure
Subjects will be exposed to filtered air for 1 hour during intermittent exercise in a purpose-built exposure facility
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
Other: CT/PET Myocardial Perfusion Imaging using O-15 water
Other: Coronary blood flow measured by doppler echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately following exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour following exposure
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
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
A 12-lead electrocardiogram will be continuously recorded using Holter ECG monitor
During and for the 24 hours aftet exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

British Heart Foundation
National Institute for Public Health and the Environment (RIVM)

Investigators

  • Principal Investigator: Jeremy P Langrish, MB BCh MRCP, University of Edinburgh
  • Study Chair: David E Newby, PhD FRCP, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2012

Primary Completion (Actual)

February 13, 2015

Study Completion (Actual)

February 13, 2015

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimated)

August 9, 2012

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIDAS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Heart Disease

Clinical Trials on CT/PET Myocardial Perfusion Imaging using O-15 water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe