Air Pollution, Inflammation and Acute Coronary Syndrome

Patients With Acute Coronary Syndrome Clinical Trial

— AIRACOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799148
• Other study ID #: AIRACOS
• Secondary ID: AIRACOS-CANARY I
• Status: Completed
• Phase: N/A
• First received: February 23, 2013
• Last updated: January 19, 2015
• Start date: November 2011
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Fundación Canaria Rafael Clavijo para la Investigación Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Inflammation
• Patients With Acute Coronary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz de Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Canaria Rafael Clavijo para la Investigación Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome:	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	Yes
Primary	Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome.	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	Yes
Secondary	Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome.	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	Yes