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The Effects of Diesel Exhaust Inhalation On Exercise Capacity In Patients With Stable Angina Pectoris

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. Identifier: NCT00737958
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : March 31, 2010
Information provided by:
University of Edinburgh

Brief Summary:
The purpose of this study is to determine whether exposure to diesel exhaust (air pollution) has a functional impact on patients with stable angina pectoris.

Condition or disease
Coronary Heart Disease Angina Pectoris

Detailed Description:
Air pollution is a major cause of cardiovascular morbidity and mortality. The mechanism and components of air pollution responsible for these cardiovascular effects are unknown but small combustion-derived particles are suspected to be the major cause. Using a unique exposure system in Umeå Sweden, we have demonstrated that healthy volunteers who inhale dilute diesel exhaust develop an impairment of two important, highly relevant and complementary aspects of vascular function: the regulation of vascular tone and endogenous fibrinolysis. We have recently extended these findings and have shown that brief exposure to dilute diesel exhaust promotes myocardial ischemia and inhibits endogenous fibrinolytic capacity in patients with stable asymptomatic coronary heart disease. We now wish to extend these findings to patients with chronic stable angina pectoris. In particular, we wish to determine the functional impact of diesel exhaust inhalation as well as describe the time course and minimum exposure that can induce these detrimental effects.

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Effects of Diesel Exhaust Inhalation On Exercise Capacity In Patients With Stable Angina Pectoris
Study Start Date : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Patients with documented stable coronary artery disease, symptoms of stable angina pectoris, and a positive standard BRUCE exercise stress test at 3 - 13 minutes.

Primary Outcome Measures :
  1. Myocardial ischaemia - measured as time to 1mm ST segment depression on the ECG during standard BRUCE exercise stress testing. [ Time Frame: Immediately after exposure ]

Secondary Outcome Measures :
  1. Total ischaemic burden - assessed using 24 hour Holter ambulatory ECG monitoring [ Time Frame: 24hrs after exposure ]
  2. Total exercise capacity - assessed by maximal work done during exercise stress test [ Time Frame: Immediately after exposure ]
  3. Biochemical evidence of myocardial ischaemia - plasma highly sensitive troponins, ischaemically modified albumin, fatty acid binding protein [ Time Frame: Before, after and at 24 hours after exposure ]

Biospecimen Retention:   Samples Without DNA
Plasma samples Serum samples

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the cardiology outpatient clinics

Inclusion Criteria:

  • Documented coronary heart disease
  • Symptoms of stable angina pectoris

Exclusion Criteria:

  • History of arrhythmia
  • Severe 3 vessel coronary artery disease or left main stem stenosis that has not been revascularised
  • Resting conduction abnormality
  • Digoxin therapy
  • Uncontrolled hypertension
  • Renal or hepatic failure
  • Patients with unstable disease (ACS or unstable symptoms within 3 months)
  • Asthma
  • Intercurrent illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00737958

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United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Sponsors and Collaborators
University of Edinburgh
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Study Director: David E Newby, MD FRCP University of Edinburgh

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Responsible Party: Dr Jeremy Langrish, University of Edinburgh Identifier: NCT00737958    
Other Study ID Numbers: BHF FS/07/048
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: July 2008
Keywords provided by University of Edinburgh:
Angina pectoris
Air pollution
Diesel exhaust
Myocardial ischaemia
Exercise capacity
Additional relevant MeSH terms:
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Heart Diseases
Angina Pectoris
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina, Stable
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Arterial Occlusive Diseases