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

Terminated

• Conditions: Angina Pectoris; Coronary Heart Disease

• Registration Number: NCT00738491
• Lead Sponsor: University of Edinburgh

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage	Throughout study period

Secondary Outcome Measures

Name	Time	Method
Exercise capacity - determined by standard BRUCE exercise stress testing	Immediately after study period
Time to 1mm ST segment depression during standard BRUCE exercise stress testing	At the end of the study period
Ambulatory blood pressure	Throughout study period
Myocardial ischaemic burden - assessed using 12-lead continuous Holter ECG monitoring	Throughout study period
Total exercise capacity - measured using GPS tracking of activity completed	Throughout study period
Biochemical evidence of myocardial ischaemia - highly sensitive troponin, ischaemically modified albumin and fatty acid binding protein	Before and after study period

Trial Locations

Locations (2)

Imperial College; 🇬🇧 London, United Kingdom

University of Edinburgh; 🇬🇧 Edinburgh, Midlothian, United Kingdom