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

This study has been completed.
Sponsor:
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00737958
First received: August 19, 2008
Last updated: March 30, 2010
Last verified: July 2008
  Purpose

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
Coronary Heart Disease
Angina Pectoris

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: The Effects of Diesel Exhaust Inhalation On Exercise Capacity In Patients With Stable Angina Pectoris

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Myocardial ischaemia - measured as time to 1mm ST segment depression on the ECG during standard BRUCE exercise stress testing. [ Time Frame: Immediately after exposure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total ischaemic burden - assessed using 24 hour Holter ambulatory ECG monitoring [ Time Frame: 24hrs after exposure ] [ Designated as safety issue: No ]
  • Total exercise capacity - assessed by maximal work done during exercise stress test [ Time Frame: Immediately after exposure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma samples Serum samples


Enrollment: 19
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with documented stable coronary artery disease, symptoms of stable angina pectoris, and a positive standard BRUCE exercise stress test at 3 - 13 minutes.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from the cardiology outpatient clinics

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00737958

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

Publications:
Responsible Party: Dr Jeremy Langrish, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00737958     History of Changes
Other Study ID Numbers: BHF FS/07/048
Study First Received: August 19, 2008
Last Updated: March 30, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Angina pectoris
Air pollution
Diesel exhaust
Myocardial ischaemia
Exercise capacity

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 20, 2014