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Acute Coronary SyndromeNCT01325155

Effect of Air Pollution in the Haifa Bay Area on Cardiovascular Morbidity and Mortality

An observational study of Acute Coronary Syndrome and Heart Failure, run by Rambam Health Care Campus.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The association between exposure to ambient air pollution and pulmonary disease has been well established.To date no study has assessed the burden of cardiovascular disease in Israel and its relation to ambient air pollution. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Coronary Syndrome, Heart Failure, Arrhythmia
How many people
5,000 participants
Where
No sites listed yet
Study dates
Apr 2011to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All Patients visiting the ER between Jan 2009 and Dec 2010 at the Rambam Medical Center in Haifa Israel. Electronic medical record databases will be queried for ICD-9 codes of related cardiac (acute coronary syndrome, heart failure, dysrhythmia/conduction disturbance) diagnoses.

Who may be able to join

  • All Patients visiting the ER between Jan 2009 and Dec 2010 at the Rambam Medical Center in Haifa Israel.

Who cannot join

  • There are no exclusion criteria

Trial locations and contacts

No sites are listed yet.

Amir Solomonica, MD MPH contact

972502062691

a_solomonica@rambam.health.gov.il

About this study

The association between exposure to ambient air pollution and pulmonary disease has been well established.To date no study has assessed the burden of cardiovascular disease in Israel and its relation to ambient air pollution.

The Haifa Bay Area has a long history of industrialization including possessing the nation's largest oil refineries, oil-fired power plant, agrochemical and cement producers, industrial incinerators and the Eastern Mediterranean's busiest port. The presence of industrial and mobile sources, combined with a basin effect has contributed to air pollution in the Haifa Bay Area and has raised concerns about potential health effects.

Read more

Research Objectives

  • Determine if the increased rate of cardiovascular mortality in Haifa is associated with PM 2.5 concentrations.
  • Assess effect modification in diverse sub-populations.
  • If an association does exist, assess the economic burden of PM 2.5 associated cardiovascular morbidity and mortality.
  • Design prediction models of daily cardiovascular emergency department visits based on daily and seasonal variation of air pollution.
Read the detailed description

The association between exposure to ambient air pollution and pulmonary disease has been well established. Recent studies have attempted to investigate the effect of air pollution, specifically exposure to PM 2.5, on cardiovascular outcomes. Acute exposure to PM 2.5 is associated with increased heart rate, decreased heart rate variability, and increased incidence of cardiac arrhythmia. Population based research from the United States and Europe has demonstrated increased rates of emergency room visits, hospitalization and cardiovascular morbidity in association with increased daily concentrations of fine particulates.

To date no study has looked at the burden of cardiovascular disease in Israel and its relation to ambient air pollution. Standardized mortality ratios due to cardiovascular disease are significantly elevated in the Haifa Bay Area in comparison to the rest of the country; mortality due to MI is 13% above national average while total ischemic heart disease mortality is 29% above national average. The Haifa Bay Area has a long history of industrialization including possessing the nation's largest oil refineries, oil-fired power plant, agrochemical and cement producers, industrial incinerators and the Eastern Mediterranean's busiest port. The presence of industrial and mobile sources, combined with a basin effect has contributed to air pollution in the Haifa Bay Area and has raised concerns about potential health effects.

Research Hypothesis- Fine particulate variation in the Haifa Bay Area is positively associated with emergency room visit,hospitalization rates and mortality rates secondary to cardiovascular disease.

Study Methodology- Critical to any environmental epidemiology research is coordination between experts in exposure assessment and health outcomes. This study will be a two year collaborative effort between the School of Public Health at the University of Haifa and the Faculty of Civil and Environmental Engineering at the Technion. Exposure measures will come from the Haifa District Municipal Association for the Environment's (HDMAE) network of 15 monitoring stations in the region. HDMAE also monitors a number of meteorological covariates (ie. maximum and minimum temperatures, mean humidity, and mean barometric pressure) which will be incorporated into exposure modeling.

Primary outcomes of interest will be daily mortality rates and daily rates of cardiovascular related emergency room visits and hospitalizations at the Rambam Medical Center in Haifa Israel. Electronic medical record databases will be queried for ICD-9 codes of related cardiac (acute coronary syndrome, heart failure, dysrhythmia/conduction disturbance) diagnoses. A time-series analysis will be utilized to assess change in mortality and emergency room visit rates in relation to incremental change in PM2.5. Covariates in the model will include seasonal trends in disease incidence, daily concentration of co-pollutants, meteorological variables such as temperature and humidity. Calculation of relative risk will incorporate a 1 through 7 day lag into the model into to determine latency of effect.

Contribution to Environmental Health in Israel- This research hopes to evaluate the contribution of ambient air pollution on the increased rate of cardiovascular morbidity in the Haifa Bay Area. In assessing effect modification in sub-groups we will contribute to the understanding of how environmental pollution impacts Israel's diverse population. In calculating the economic impact of associated morbidity and mortality we hope to contribute to the cost-benefit analysis of environmental regulation in Israel. Finally, by creating prediction models of daily cardiovascular emergency department visits based on air pollution and meteorlogical variation, we can potentially inform local medical facilities and public health agencies on how to predict and prepare for changes in disease incidence.

Keywords
Air Pollution, particulate matter, cardiovascular Disease
Medical subject headings
Acute Coronary Syndrome, Heart Failure, Arrhythmias, Cardiac, Cardiovascular Diseases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2011 (estimated)
  2. Study startApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01325155
Sponsor's protocol ID
0043-11CTIL
Status last verified
Mar 2011
First submitted
27 Mar 2011
Last updated
29 Mar 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Coronary Syndrome and Heart Failure, run by Rambam Health Care Campus.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Amir Solomonica, MD MPH (972502062691, a_solomonica@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2011.

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