ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effects of Ambient Air Pollution Exposure in Patients With Stable Angina Pectoris During Normal Daily Activities

This study is currently recruiting participants.
Verified by University of Edinburgh, August 2008

Sponsors and Collaborators: University of Edinburgh
Imperial College London
Information provided by: University of Edinburgh
ClinicalTrials.gov Identifier: NCT00738491
  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

MedlinePlus related topics:   Air Pollution    Angina    Exercise and Physical Fitness    Heart Diseases   

U.S. FDA Resources

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

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

Biospecimen Description:

Plasma samples Serum samples


Estimated Enrollment:   100
Study Start Date:   August 2008
Estimated Study Completion Date:   August 2009
Estimated Primary Completion Date:   August 2009 (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

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

Contacts
Contact: Jeremy P Langrish, MB BCh     +44 131 242 6438     jeremy.langrish@ed.ac.uk    
Contact: Nicholas L Mills, MB BCh     +44 131 242 1850     nick.mills@ed.ac.uk    

Locations
United Kingdom
Imperial College     Not yet recruiting
      London, United Kingdom, SW3 6LY
      Contact: Philip A Poole-Wilson, MD FRCP FMedSci     +44 (0) 20 7351 8113     p.poole-wilson@imperial.ac.uk    
      Principal Investigator: Philip A Poole-Wilson, MD FRCP            
United Kingdom, Midlothian
University of Edinburgh     Recruiting
      Edinburgh, Midlothian, United Kingdom, EH16 4SB
      Contact: Jeremy P Langrish, MB BCh     +44 131 242 6438     jeremy.langrish@ed.ac.uk    
      Contact: Nicholas L Mills, MB BCh     +44 131 242 1850     nick.mills@ed.ac.uk    
      Principal Investigator: Jeremy P Langrish, MB BCh            
      Sub-Investigator: Nicholas L Mills, MB BCh            

Sponsors and Collaborators
University of Edinburgh
Imperial College London
  More Information


Publications:

Responsible Party:   University of Edinburgh ( Dr Jeremy Langrish )
Study ID Numbers:   08/S1101/6
First Received:   August 19, 2008
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00738491
Health Authority:   United Kingdom: Research Ethics Committee

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

Study placed in the following topic categories:
Coronary Disease
Signs and Symptoms
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Angina Pectoris
Pain
Ischemia
Chest Pain

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008




Links to all studies - primarily for crawlers