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Air Pollution, Inflammation and Acute Coronary Syndrome (AIRACOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alberto Domínguez Rodríguez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier:
NCT01799148
First received: February 23, 2013
Last updated: January 19, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Patients With Acute Coronary Syndrome
Other: Particulate air pollutants

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 360 Days
Official Title: Impact of AIR Pollution on Inflammation, Oxidative Stress and 1-year Prognosis in Patients Hospitalized for Acute COronary Syndrome

Resource links provided by NLM:


Further study details as provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:

Primary Outcome Measures:
  • Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome: [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 307
Study Start Date: November 2011
Study Completion Date: November 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01799148

Locations
Spain
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, E-38320
Sponsors and Collaborators
Fundación Canaria Rafael Clavijo para la Investigación Biomédica
  More Information

No publications provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alberto Domínguez Rodríguez, Alberto Dominguez Rodriguez, Fundación Canaria Rafael Clavijo para la Investigación Biomédica
ClinicalTrials.gov Identifier: NCT01799148     History of Changes
Other Study ID Numbers: AIRACOS, AIRACOS-CANARY ISLANDS
Study First Received: February 23, 2013
Last Updated: January 19, 2015
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundación Canaria Rafael Clavijo para la Investigación Biomédica:
Acute coronary syndrome
Air pollution.
Inflammation.
Oxidative Stress.
Prognosis

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015