Controlled Exposures to Air Pollution in Patients With Coronary Heart Disease
The Effects of Air Pollution on Vascular and Endogenous Fibrinolytic Function in Patients With Coronary Heart Disease
1 other identifier
interventional
20
1 country
1
Brief Summary
Air pollution is a major cause of cardiovascular morbidity and mortality. The components of air pollution responsible and the mechanisms through which they might mediate these harmful effects remain only partially understood. We hypothesise that these adverse effects are mediated by combustion derived air pollutants and that even a brief exposure will effect heart and blood vessel function. We assess the effect of dilute diesel exhaust inhalation at levels encountered in urban road traffic on heart and blood vessel function in patients with stable coronary heart disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2006
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedFebruary 19, 2007
February 1, 2007
February 16, 2007
February 16, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Exercise induced myocardial ischemia
Vascular vasomotor function
Endogenous fibrinolytic function
Interventions
Eligibility Criteria
You may qualify if:
- Previous myocardial infarction (\>6 months previously) treated by primary angioplasty and stenting
- On standard secondary preventative therapy
You may not qualify if:
- Angina pectoris (Canadian Cardiovascular Society grade ≥2)
- History of arrhythmia
- Diabetes mellitus
- Uncontrolled hypertension
- Renal or hepatic failure
- Unstable coronary disease (acute coronary syndrome or unstable symptoms within 3 months)
- Occupational exposure to air pollution
- Current smokers
- Asthma
- Inter-current illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- Umeå Universitycollaborator
Study Sites (1)
Umeå University
Umeå, Västerbotten County, 901 85, Sweden
Related Publications (2)
Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.
PMID: 24667535DERIVEDMills NL, Tornqvist H, Gonzalez MC, Vink E, Robinson SD, Soderberg S, Boon NA, Donaldson K, Sandstrom 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. doi: 10.1056/NEJMoa066314.
PMID: 17855668DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David E Newby, MD
University of Edinburgh
- PRINCIPAL INVESTIGATOR
Thomas Sandstrom, MD
Umeå University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
April 1, 2006
Study Completion
June 1, 2006
Last Updated
February 19, 2007
Record last verified: 2007-02