NCT00737958

Brief Summary

The purpose of this study is to determine whether exposure to diesel exhaust (air pollution) has a functional impact on patients with stable angina pectoris.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 31, 2010

Status Verified

July 1, 2008

Enrollment Period

4 months

First QC Date

August 19, 2008

Last Update Submit

March 30, 2010

Conditions

Coronary Heart DiseaseAngina Pectoris

Keywords

Angina pectorisAir pollutionDiesel exhaustMyocardial ischaemiaExercise capacity

Outcome Measures

Primary Outcomes (1)

  • Myocardial ischaemia - measured as time to 1mm ST segment depression on the ECG during standard BRUCE exercise stress testing.

    Immediately after exposure

Secondary Outcomes (3)

  • Total ischaemic burden - assessed using 24 hour Holter ambulatory ECG monitoring

    24hrs after exposure

  • Total exercise capacity - assessed by maximal work done during exercise stress test

    Immediately after exposure

  • Biochemical evidence of myocardial ischaemia - plasma highly sensitive troponins, ischaemically modified albumin, fatty acid binding protein

    Before, after and at 24 hours after exposure

Study Arms (1)

1

Patients with documented stable coronary artery disease, symptoms of stable angina pectoris, and a positive standard BRUCE exercise stress test at 3 - 13 minutes.

Eligibility Criteria

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

Patients will be recruited from the cardiology outpatient clinics

You may qualify if:

  • Documented coronary heart disease
  • Symptoms of stable angina pectoris

You may not qualify if:

  • History of arrhythmia
  • Severe 3 vessel coronary artery disease or left main stem stenosis that has not been revascularised
  • Resting conduction abnormality
  • Digoxin therapy
  • Uncontrolled hypertension
  • Renal or hepatic failure
  • Patients with unstable disease (ACS or unstable symptoms within 3 months)
  • Asthma
  • Intercurrent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Midlothian, EH16 4SB, United Kingdom

Location

Related Publications (5)

  • 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

  • Lanki T, Hoek G, Timonen KL, Peters A, Tiittanen P, Vanninen E, Pekkanen J. Hourly variation in fine particle exposure is associated with transiently increased risk of ST segment depression. Occup Environ Med. 2008 Nov;65(11):782-6. doi: 10.1136/oem.2007.037531. Epub 2008 Jun 4.

    PMID: 18524840BACKGROUND

  • Pekkanen J, Peters A, Hoek G, Tiittanen P, Brunekreef B, de Hartog J, Heinrich J, Ibald-Mulli A, Kreyling WG, Lanki T, Timonen KL, Vanninen E. Particulate air pollution and risk of ST-segment depression during repeated submaximal exercise tests among subjects with coronary heart disease: the Exposure and Risk Assessment for Fine and Ultrafine Particles in Ambient Air (ULTRA) study. Circulation. 2002 Aug 20;106(8):933-8. doi: 10.1161/01.cir.0000027561.41736.3c.

    PMID: 12186796BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples Serum samples

MeSH Terms

Conditions

Coronary DiseaseAngina PectorisCoronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • David E Newby, MD FRCP

    University of Edinburgh

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 31, 2010

Record last verified: 2008-07

Locations

GB(1)