NCT01799148

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

2.7 years

First QC Date

February 23, 2013

Last Update Submit

January 19, 2015

Conditions

Patients With Acute Coronary Syndrome

Keywords

Acute coronary syndromeAir pollution.Inflammation.Oxidative Stress.Prognosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome.

    1 year

Other Outcomes (1)

  • Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome:

    1 year

Study Arms (1)

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

Interventions

Particulate air pollutantsOTHER

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.

Particulate air pollutants

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients with acute coronary syndrome

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz de Tenerife, E-38320, Spain

Location

Related Publications (1)

  • Dominguez-Rodriguez A, Rodriguez S, Abreu-Gonzalez P, Avanzas P. [Impact of air pollution on inflammation, oxidative stress and 1-year prognosis in patients hospitalized for acute coronary syndrome: design of the AIRACOS study]. Med Clin (Barc). 2013 Dec 21;141(12):529-32. doi: 10.1016/j.medcli.2013.05.024. Epub 2013 Jul 25. No abstract available. Spanish.

    PMID: 23891131DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeInflammation

Interventions

Particulate Matter

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
360 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alberto Dominguez Rodriguez

Study Record Dates

First Submitted

February 23, 2013

First Posted

February 26, 2013

Study Start

November 1, 2011

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

ES(1)