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

December 1, 2014 updated by: Jeremy Langrish, University of Edinburgh
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

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6LY
        • Imperial College
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH16 4SB
        • University of Edinburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stable angina pectoris and documented coronary artery disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Patients with stable angina pectoris and documented coronary heart disease recruited in Edinburgh
2
Patients with stable angina pectoris and documented coronary heart disease recruited in London

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage
Time Frame: Throughout study period
Throughout study period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Imperial College London

Investigators

  • Principal Investigator: Jeremy P Langrish, MB BCh, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

August 19, 2008

First Submitted That Met QC Criteria

August 19, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08/S1101/6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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