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

NCT ID: NCT00737958

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Heart Disease Angina Pectoris

Keywords

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Angina pectoris Air pollution Diesel exhaust Myocardial ischaemia Exercise capacity

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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University of Edinburgh

Principal Investigators

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David E Newby, MD FRCP

Role: STUDY_DIRECTOR

University of Edinburgh

Locations

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University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 17855668 (View on PubMed)

Tornqvist H, Mills NL, Gonzalez M, Miller MR, Robinson SD, Megson IL, Macnee W, Donaldson K, Soderberg S, Newby DE, Sandstrom T, Blomberg A. Persistent endothelial dysfunction in humans after diesel exhaust inhalation. Am J Respir Crit Care Med. 2007 Aug 15;176(4):395-400. doi: 10.1164/rccm.200606-872OC. Epub 2007 Apr 19.

Reference Type BACKGROUND
PMID: 17446340 (View on PubMed)

Mills NL, Tornqvist H, Robinson SD, Gonzalez M, Darnley K, MacNee W, Boon NA, Donaldson K, Blomberg A, Sandstrom T, Newby DE. Diesel exhaust inhalation causes vascular dysfunction and impaired endogenous fibrinolysis. Circulation. 2005 Dec 20;112(25):3930-6. doi: 10.1161/CIRCULATIONAHA.105.588962.

Reference Type BACKGROUND
PMID: 16365212 (View on PubMed)

Lanki T, Hoek G, Timonen KL, Peters A, Tiittanen P, Vanninen E, Pekkanen J. Hourly variation in fine particle exposure is associated with transiently increased risk of ST segment depression. Occup Environ Med. 2008 Nov;65(11):782-6. doi: 10.1136/oem.2007.037531. Epub 2008 Jun 4.

Reference Type BACKGROUND
PMID: 18524840 (View on PubMed)

Pekkanen J, Peters A, Hoek G, Tiittanen P, Brunekreef B, de Hartog J, Heinrich J, Ibald-Mulli A, Kreyling WG, Lanki T, Timonen KL, Vanninen E. Particulate air pollution and risk of ST-segment depression during repeated submaximal exercise tests among subjects with coronary heart disease: the Exposure and Risk Assessment for Fine and Ultrafine Particles in Ambient Air (ULTRA) study. Circulation. 2002 Aug 20;106(8):933-8. doi: 10.1161/01.cir.0000027561.41736.3c.

Reference Type BACKGROUND
PMID: 12186796 (View on PubMed)

Other Identifiers

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BHF FS/07/048

Identifier Type: -

Identifier Source: org_study_id