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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00738491
• Other study ID #: 08/S1101/6
• Status: Terminated
• Phase: N/A
• First received: August 19, 2008
• Last updated: December 1, 2014
• Start date: August 2008
• Est. completion date: August 2013

Study information

• Verified date: December 2014
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh	Midlothian
United Kingdom	Imperial College	London

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

Mills NL, Törnqvist H, Gonzalez MC, Vink E, Robinson SD, Söderberg S, Boon NA, Donaldson K, Sandström 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. — View Citation

Mills NL, Törnqvist 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. — View Citation

Törnqvist H, Mills NL, Gonzalez M, Miller MR, Robinson SD, Megson IL, Macnee W, Donaldson K, Söderberg S, Newby DE, Sandström 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. Epub 2007 Apr 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage		Throughout study period	No
Secondary	Myocardial ischaemic burden - assessed using 12-lead continuous Holter ECG monitoring		Throughout study period	No
Secondary	Time to 1mm ST segment depression during standard BRUCE exercise stress testing		At the end of the study period	No
Secondary	Total exercise capacity - measured using GPS tracking of activity completed		Throughout study period	No
Secondary	Exercise capacity - determined by standard BRUCE exercise stress testing		Immediately after study period	No
Secondary	Ambulatory blood pressure		Throughout study period	No
Secondary	Biochemical evidence of myocardial ischaemia - highly sensitive troponin, ischaemically modified albumin and fatty acid binding protein		Before and after study period	No