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Effects of Ambient Air Pollution Exposure in Patients With Stable Angina Pectoris During Normal Daily Activities

NCT ID: NCT00738491

Last Updated: 2014-12-02

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

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this study is to identify whether exposure to ambient levels of air pollution during normal daily activities has a functional impact on patients with coronary heart disease

Detailed Description

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Exposure to air pollution has been shown in epidemiological studies to be closely linked to cardiovascular morbidity and mortality. The exact components of air pollution that underlie the cardiovascular effects are not yet known, but combustion-derived particulate matter is suspected to be the major cause. In controlled exposure studies, we have recently demonstrated that exposure to diesel exhaust causes increased myocardial ischaemia with exercise in patients with asymptomatic coronary artery disease. The mechanism behind this effect is not yet understood, but we have shown that diesel exhaust exposure causes an acute impairment of two important and highly relevant aspects of vascular tone: vasomotor tone and endogenous fibrinolysis. In this study we propose to investigate the effects of exposure to ambient levels of air pollution on patients with stable, symptomatic angina pectoris, during their daily lives.

Conditions

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Angina Pectoris Coronary Heart Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with stable angina pectoris and documented coronary heart disease recruited in Edinburgh

No interventions assigned to this group

2

Patients with stable angina pectoris and documented coronary heart disease recruited in London

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Documented coronary artery disease
* Symptoms of stable angina pectoris
* Positive BRUCE exercise stress test between 3 and 13 minutes

Exclusion Criteria

* History of arrhythmia
* Severe 3 vessel coronary disease or left main stem stenosis that has not been revascularised
* Resting conduction abnormality
* Digoxin therapy
* Uncontrolled hypertension
* Renal or hepatic failure
* Unstable symptoms or acute coronary syndrome within 3 months
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Langrish

Clinical Lecturer and Specialty Registrar in Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy P Langrish, MB BCh

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Site Status

Imperial College

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. doi: 10.1056/NEJMoa071535.

Reference Type BACKGROUND
PMID: 18057337 (View on PubMed)

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)

Other Identifiers

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08/S1101/6

Identifier Type: -

Identifier Source: org_study_id