Air Pollution, Inflammation and Acute Coronary Syndrome (AIRACOS)

January 19, 2015 updated by: Alberto Domínguez Rodríguez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Impact of AIR Pollution on Inflammation, Oxidative Stress and 1-year Prognosis in Patients Hospitalized for Acute COronary Syndrome

The objectives of this study are: 1) To determine whether patients with acute coronary syndrome, the level of environmental exposure to particulate air pollutants in the week prior to admission, are related to concentrations of inflammatory molecules and oxidative stress. 2) To investigate whether the level of environmental exposure is an independent prognostic factor in terms of overall and cardiovascular mortality, myocardial infarction or unstable angina at 30 days, 6 and 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Santa Cruz de Tenerife
      • La Laguna, Santa Cruz de Tenerife, Spain, E-38320
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cohort of consecutive patients admitted with diagnosis of aucte coronary, which will quantify the exposure of particulate air pollutants 24 hours a day 7 days earlier prior to admission. Also be determined inflammatory molecules and oxidative stress in admission. During the evolution of these patients, after 30 days, 6 and 12 months will recorded major adverse cardiovascular events. It also will quantify the exposure of air pollutant particles, in all patients included at 30 days, 6 and 12 months.

Description

Inclusion Criteria:

  • Patients with acute coronary syndrome

Exclusion Criteria:

  • Infectious process and / or local or systemic inflammation in the 15 days before admission.
  • Thyrotoxicosis.
  • Neoplasms - or any other disease that seriously compromise the prognosis of life and / or generate a systemic inflammatory response.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Particulate air pollutants
Cohort of consecutive patients admitted with diagnosis of acute coronary syndrome in the cardiology unit of a tertiary hospital, which will quantify the exposure of particulate air pollutants 24 hours a day 7 days earlier prior to admission.
Other: Particulate air pollutants
We will determined the average concentrations of different sizes of particulate matter from 1 day or up to 7 days prior to admission in patients with acute coronary syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome.
Time Frame: 7 days
A single center, cohort of consecutive patients admitted with diagnosis of acute coronary syndrome in the cardiology unit of a tertiary hospital, which will quantify the exposure of particulate air pollutants 24 hours a day 7 days earlier prior to admission. Also be determined inflammatory molecules and oxidative stress in admission.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome.
Time Frame: 1 year
During the evolution of these patients, after 30 days, 6 and 12 months will recorded major adverse cardiovascular events. It also will quantify the exposure of air pollutant particles in all patients included, at 30 days, 6 and 12 months.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome:
Time Frame: 1 year
During the evolution of these patients, after 30 days, 6 and 12 months will recorded major adverse cardiovascular events. It also will quantify the exposure of air pollutant particles in all patients included, at 30 days, 6 and 12 months.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

February 23, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRACOS
  • AIRACOS-CANARY ISLANDS (Other Identifier: Hospital Universitario de Canarias)

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.

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