- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437138
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Observational studies suggest that exposure to air pollution may worsen symptoms of angina and trigger acute myocardial infarction. These findings are limited by imprecision in the measurement of pollution exposure, the effect of potential confounding environmental and social factors, and the lack of mechanistic data. Controlled exposures of air pollutants can help to address these shortcomings by providing a precisely defined exposure in a regulated environment that facilitates investigation with validated biomarkers and surrogate measures of cardiovascular health. Using a carefully characterised exposure system, we have previously shown in healthy volunteers that exposure to dilute diesel exhaust causes lung inflammation, depletion of airway antioxidant defences, and impairment of vascular and fibrinolytic function. To date, there have been no controlled exposures in patients with coronary heart disease: an important population who may be particularly susceptible to the adverse cardiovascular effects of air pollution.
In a double blind randomized cross-over study, 20 patients with prior myocardial infarction will be exposed to dilute diesel exhaust (300µg/m3) or filtered air during periods of rest and moderate exercise in a controlled exposure facility. During the exposure, myocardial ischemia will be quantified by ST-segment analysis using continuous 12-lead electrocardiography. Six hours following exposure, vascular vasomotor and fibrinolytic function will be assessed by means of intra-arterial agonist infusions.
Study Type
Enrollment
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Västerbotten
-
Umeå, Västerbotten, Sweden, 901 85
- Umea University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Previous myocardial infarction (>6 months previously) treated by primary angioplasty and stenting
- On standard secondary preventative therapy
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Exercise induced myocardial ischemia
|
Vascular vasomotor function
|
Endogenous fibrinolytic function
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David E Newby, MD, University of Edinburgh
- Principal Investigator: Thomas Sandstrom, MD, Umea University
Publications and helpful links
General Publications
- 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.
- Mills 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG/05/003 DISARM 2
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.
Clinical Trials on Coronary Heart Disease
-
Peking University Third HospitalCompletedCoronary Microvascular Dysfunction | Obstructive Coronary Heart DiseaseChina
-
Shenyang Northern HospitalNot yet recruitingCoronary Heart Disease (CHD)China
-
Johns Hopkins UniversityCanon Medical Systems, USARecruiting
-
MedImmune LLCCompletedStable Coronary Heart DiseaseUnited States
-
Medical University of LodzBaxter Healthcare CorporationUnknownCHD - Coronary Heart DiseasePoland
-
University of ZurichCompletedStable Coronary Heart DiseaseSwitzerland
-
Hamad Medical CorporationMayo ClinicCompleted
-
Centro de estudios en Cardiologia IntervencionistaCompletedCoronary Heart Disease | Coronary RestenosisArgentina
-
Deutsches Herzzentrum MuenchenCompletedCoronary Heart DiseaseGermany
-
AstraZenecaCompleted
Clinical Trials on Exposure to dilute diesel exhaust (300µg/m3) or filtered air
-
University of British ColumbiaOttawa Hospital Research Institute; Government of AlbertaCompleted
-
University of AthensRecruitingAtherosclerosisGreece
-
University of British ColumbiaNatural Sciences and Engineering Research Council, Canada; Canadian Academy... and other collaboratorsCompletedAir Pollution | Exercise-induced BronchoconstrictionCanada