2007 Progress Report: Epidemiological Studies on Extra Pulmonary Effects of Fresh and Aged Urban Aerosols from Different Sources

EPA Grant Number: R832415C002
Subproject: this is subproject number 002 , established and managed by the Center Director under grant R832415
(EPA does not fund or establish subprojects; EPA awards and manages the overall grant for this center).

Center: Rochester PM Center
Center Director: Oberdörster, Günter
Title: Epidemiological Studies on Extra Pulmonary Effects of Fresh and Aged Urban Aerosols from Different Sources
Investigators: Peters, Annette , Utell, Mark J. , Schneider, Alexandra , Meisinger, Christa , Wichmann, Heinz-Erich , Brüske-Hohlfeld, Irene , Cyrus, Josef , Stolzel, Matthias , Pitz, Mike , Belcredi, Petra , Rückerl, Regina , Hampel, Regina , Holle, Rolf , Breitner, Susanne , Illig, Thomas , Küpper, Ute , Koenig, Wolfgang
Current Investigators: Peters, Annette , Zareba, Wojciech , Utell, Mark J. , Henneberger, Alexandra , Wichmann, Heinz-Erich , Stoelzel, M , Rückerl, Regina , Phipps, Richard , Breitner, Susanne
Institution: GSF-National Research Center for Environment and Health , University of Augsburg , KORA-Studienzentrum , University of Rochester , University of Uhm
Current Institution: GSF-National Research Center for Environment and Health , University of Rochester
EPA Project Officer: Chung, Serena
Project Period: October 1, 2005 through September 30, 2010 (Extended to September 30, 2012)
Project Period Covered by this Report: October 1, 2006 through September 30,2007
RFA: Particulate Matter Research Centers (2004) RFA Text |  Recipients Lists
Research Category: Human Health , Air

Objective:

The aim of the epidemiological study is to determine the effect of fine and ultrafine particles on the acute phase reaction in the blood and pro-thrombotic states of the blood. Particles are measured at a central measurement site in Augsburg and ? for a subset of 30 individuals in each panel ? personal measurements of ultrafine particles are also undertaken using a portable condensation particle counter (CPC) as well as temperature, humidity and noise. For the subset of patients an ECG measurement and the measurement of endothelial function are scheduled in addition to the personal measurements. In Augsburg three panels are enrolled aiming at a total of 240 subjects. The panels consist of:

Panel 1: Subjects with type 2 diabetes
Panel 2: Subjects with impaired glucose tolerance (IGT)
Panel 3: Healthy subjects with potential genetic susceptibility:

(GSTM1 00 plus rs1205 CC or rs 1800790 AA/AG)

With regard to the proposal this represents a change in the original study plan. The scope of the project was revised as proposed at the SAC 2006 Meeting. The reasons for the change were a considerable under budgeting of (a) the personal monitoring equipment and the related efforts, (b) the blood analyses and (c) ECG-analyses. In addition, additional efforts were devoted to implement endothelial dysfunction measurements as suggested by the SAC. After the experiences with a large European multicenter panel study, the AIRGENE study, myocardial infarction survivors were considered to be too heavily medicated to observe changes in their blood markers. In addition, the number of repeated measurements was increased from 6 to 8 per person, to be able to securely measure the within-person variability and to extract the air pollution component.

Progress Summary:

A pilot phase was conducted between 19thand 23rdof February on six test patients. Newly established methods and devices were tested and feedback was given from the study nurses to the coordinating centre. No major changes in the study protocol seemed necessary; however, two special belts for an easier attachment of the 24hr Mortara ECG device were manufactured. The main phase started on the 19thof March 2007.

Patient selection

For the main phase we selected three panels as described above. The frequency of the genetically susceptible patients in our baseline population can be found in table 1.

Table 1: Frequency of selected SNPs of the Fibrinogen-Gen within the potential participants of the EPA STAR study, panel of genetically susceptible patients.

Table 1: Frequency of selected SNPs of the Fibrinogen-Gen within the potential participants of the EPA STAR study, panel of genetically susceptible patients. Non-smokers without diabetes, without intake of platelet aggregation inhibitors and without heart surgery.

Patient recruitment
The recruitment is still ongoing. Up to the 25th of May 46 patients had been recruited by telephone, one of which had to be excluded as he did not fulfill the inclusion criteria. The 45 patients divide into 13 diabetics, 13 patients with IGT (equaling 16% of the targeted 80 patients for each group) and 19 genetically susceptible patients (24% of the targeted patients). Sixteen patients agreed to take part in the personal measurements, nine diabetics, six patients with IGT and 1 of the genetically susceptible patients. Seven patients refused to participate and 22 are still undecided. The personal measurements start at the second visit.

Examinations

In the first ten weeks of the field phase 73 examinations have been conducted with a maximum of three visits per patient. An overview over the total number of visits in each group is given in table 2.

Table 2. overview over the number of visits conducted in the first 10 weeks of the field phase and the participation in the personal measurements.

Table 2. overview over the number of visits conducted in the first 10 weeks of the field phase and the participation in the personal measurements.

Out of 19 personal CPC measurements 14 were complete (74%). In four cases less than 3 hours (target: about 5 hours) were recorded. The existing data can still be used, however the measurements are incomplete. The reason for the incomplete data is unclear yet, however the technicians are working on the problem in close collaboration with the manufacturer of the device (TSI, Shoreview, MN, USA). Two measurements got lost due to a break in the cable that is needed to download the data from the CPC to the computer. This problem could be fixed.

A graph with the CPC measurement data is provided to the patients at their following visit. Therefore, prompt checks of data on a regular basis are conducted by the coordinating centre. A preliminary analysis of the pilot phase has been presented at the EPA-GSF meeting in Montreat, NC, in spring 2007. First results from the pilot study indicate a good relation between personal exposure and the data of the central measurement site on an hourly basis depending on time spent indoors and ventilation habit of the study subjects. However, these analyses are limited to only few people (n=5) and the results of the main phase are yet to come.

Ultrafine Particles and Cardiac Effects: Evaluation in a Cardiac Rehabilitation Center

Investigators: Mark Utell, William Beckett, Philip Hopke, Laurie Kopin, Wojciech Zareba, John Bisognano.
Institutions: University of Rochester School of Medicine and Dentistry; Clarkson University

The objective of this study is to determine whether, in 75 patients undergoing cardiac rehabilitation for coronary disease, levels of ultrafine particles are associated with ECG changes, complete blood count serum fibrinogen or C-reactive protein levels. This study is active with ongoing measurements of ultrafine particles in the community, cardiac center, and in a subset of subjects homes and motor vehicles. Approximately 17 subjects have been enrolled. Data on variation of subject exposures to ambient, rehab center, indoor home, and inside vehicle ultrafine particles will be presented at the SAC meeting.

References:

Daumer M et al.  Steps towards a miniaturized, robust and autonomous measurement device for the long-term monitoring of patient activity: ActiBelt.  Biomed Tech. 2007;52:149–155.

Journal Articles:

No journal articles submitted with this report: View all 19 publications for this subproject

Supplemental Keywords:

RFA, Health, PHYSICAL ASPECTS, Scientific Discipline, Air, particulate matter, Health Risk Assessment, Epidemiology, Risk Assessments, Physical Processes, atmospheric particulate matter, atmospheric particles, long term exposure, acute cardiovascular effects, airway disease, exposure, human exposure, ambient particle health effects, atmospheric aerosol particles, PM, aersol particles, cardiovascular disease

Progress and Final Reports:

Original Abstract
  • 2006 Progress Report
  • 2008 Progress Report
  • 2009 Progress Report
  • 2010 Progress Report
  • 2011 Progress Report
  • Final Report

  • Main Center Abstract and Reports:

    R832415    Rochester PM Center

    Subprojects under this Center: (EPA does not fund or establish subprojects; EPA awards and manages the overall grant for this center).
    R832415C001 Characterization and Source Apportionment
    R832415C002 Epidemiological Studies on Extra Pulmonary Effects of Fresh and Aged Urban Aerosols from Different Sources
    R832415C003 Human Clinical Studies of Concentrated Ambient Ultrafine and Fine Particles
    R832415C004 Animal models: Cardiovascular Disease, CNS Injury and Ultrafine Particle Biokinetics
    R832415C005 Ultrafine Particle Cell Interactions In Vitro: Molecular Mechanisms Leading To Altered Gene Expression in Relation to Particle Composition