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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Edinburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Jeremy Langrish, University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00738491
First received: August 19, 2008
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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


Condition
Angina Pectoris
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effects of Ambient Air Pollution Exposure in Patients With Stable Angina Pectoris During Normal Daily Activities

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Myocardial ischaemic burden - assessed using 12-lead continuous Holter ECG monitoring [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Time to 1mm ST segment depression during standard BRUCE exercise stress testing [ Time Frame: At the end of the study period ] [ Designated as safety issue: No ]
  • Total exercise capacity - measured using GPS tracking of activity completed [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Exercise capacity - determined by standard BRUCE exercise stress testing [ Time Frame: Immediately after study period ] [ Designated as safety issue: No ]
  • Ambulatory blood pressure [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Biochemical evidence of myocardial ischaemia - highly sensitive troponin, ischaemically modified albumin and fatty acid binding protein [ Time Frame: Before and after study period ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma samples Serum samples


Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with stable angina pectoris and documented coronary artery disease

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738491

Locations
United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH16 4SB
Imperial College
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
University of Edinburgh
Imperial College London
Investigators
Principal Investigator: Jeremy P Langrish, MB BCh University of Edinburgh
  More Information

Publications:
Responsible Party: Jeremy Langrish, Clinical Lecturer and Specialty Registrar in Cardiology, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00738491     History of Changes
Other Study ID Numbers: 08/S1101/6
Study First Received: August 19, 2008
Last Updated: November 30, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Angina pectoris
Exercise capacity
Myocardial ischaemia
Air pollution

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Angina, Stable
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 26, 2014