NCT00738491

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

5 years

First QC Date

August 19, 2008

Last Update Submit

December 1, 2014

Conditions

Angina PectorisCoronary Heart Disease

Keywords

Angina pectorisExercise capacityMyocardial ischaemiaAir pollution

Outcome Measures

Primary Outcomes (1)

  • Symptoms of angina pectoris - assessed by symptom diary and reliever medication usage

    Throughout study period

Secondary Outcomes (6)

  • Myocardial ischaemic burden - assessed using 12-lead continuous Holter ECG monitoring

    Throughout study period

  • Time to 1mm ST segment depression during standard BRUCE exercise stress testing

    At the end of the study period

  • Total exercise capacity - measured using GPS tracking of activity completed

    Throughout study period

  • Exercise capacity - determined by standard BRUCE exercise stress testing

    Immediately after study period

  • Ambulatory blood pressure

    Throughout study period

  • +1 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stable angina pectoris and documented coronary artery disease

You may qualify if:

  • Documented coronary artery disease
  • Symptoms of stable angina pectoris
  • Positive BRUCE exercise stress test between 3 and 13 minutes

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

Location

Imperial College

London, SW3 6LY, United Kingdom

Location

Related Publications (4)

  • McCreanor J, Cullinan P, Nieuwenhuijsen MJ, Stewart-Evans J, Malliarou E, Jarup L, Harrington R, Svartengren M, Han IK, Ohman-Strickland P, Chung KF, Zhang J. Respiratory effects of exposure to diesel traffic in persons with asthma. N Engl J Med. 2007 Dec 6;357(23):2348-58. doi: 10.1056/NEJMoa071535.

    PMID: 18057337BACKGROUND

  • 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.

    PMID: 17855668BACKGROUND

  • Tornqvist H, Mills NL, Gonzalez M, Miller MR, Robinson SD, Megson IL, Macnee W, Donaldson K, Soderberg S, Newby DE, Sandstrom T, Blomberg A. Persistent endothelial dysfunction in humans after diesel exhaust inhalation. Am J Respir Crit Care Med. 2007 Aug 15;176(4):395-400. doi: 10.1164/rccm.200606-872OC. Epub 2007 Apr 19.

    PMID: 17446340BACKGROUND

  • Mills NL, Tornqvist H, Robinson SD, Gonzalez M, Darnley K, MacNee W, Boon NA, Donaldson K, Blomberg A, Sandstrom T, Newby DE. Diesel exhaust inhalation causes vascular dysfunction and impaired endogenous fibrinolysis. Circulation. 2005 Dec 20;112(25):3930-6. doi: 10.1161/CIRCULATIONAHA.105.588962.

    PMID: 16365212BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples Serum samples

MeSH Terms

Conditions

Angina PectorisCoronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Jeremy P Langrish, MB BCh

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Lecturer and Specialty Registrar in Cardiology

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

GB(2)