Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
Sponsorpablo Juan-Salvadores

About this trial

The new global guidelines from the World Health Organization on air quality provide evidence of the damage that air pollution inflicts on human health at even lower concentrations than previously thought. Different studies have shown an increase in the incidence of coronary artery disease (CAD) in young people in recent decades. The main objective of this project is to study the impact of environmental pollutants on the premature manifestation of CAD from different epidemiological approaches and their impact on the evolution of these patients with a gender perspective. It is a retrospective analytical case-control study nested in a cohort of patients ≤40 years old with a clinical history of CAD including: ST-segment elevation myocardial infarction, non-ST-segment elevation acute coronary syndrome, unstable angina, stable angina or silent angina according to the international classification of diseases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women and men between 18 and 40 years old with a diagnosis of coronary artery disease coded in their medical records in Galicia

Disqualifiers

Not having a postal code and primary care center assigned in their medical records in Galicia

Women and men between 18 and 40 years old with no diagnosis or history of CAD or other coronary disease coded in their medical records

Present with non-ischemic coronary diseas.

Have a serious condition that affects or decreases life expectancy.

Trial population

This study focuses on patients aged ≤40 years with a diagnosis of coronary artery disease (CAD) recorded in the clinical history of Galicia (IANUS), including: ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTACS), unstable angina, stable angina, or silent angina according to the International Classification of Diseases (ICD-10). Given the limited number of cases, to increase the statistical power of the project, three patients without a diagnosis of CAD (controls) will be used for each patient with CAD confirmed by coronary angiography (case), matched by postal code and primary care center.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

4,272 Participants
are grouped into 2 trial groups
Group A: Premature Coronary Artery Disease
Group B: Non Coronary Artery Disease

Trial outcomes

Primary outcomes

1

To determine the differences in exposure to environmental pollutants in patients ≤40 years old with and without coronary artery disease

The study will measure the levels of environmental pollutants (such as PM2.5, PM10, nitrogen dioxide (NO2), carbon monoxide (CO), and ozone (O3), among others) in patients ≤40 years old with a clinical diagnosis of coronary artery disease and in patients without a diagnosis of coronary artery disease, in order to compare the differences.

Time frame
15 years
2

To evaluate the impact of environmental pollutants on the incidence of the combined variable of major adverse cardiovascular events (MACE) up to 1, 5, and 10 years from the index cas

To evaluate the impact of environmental pollutants on the incidence of the combined variable of major adverse cardiovascular events (MACE) up to 1, 5, and 10 years from the index cas

Time frame
15 years
3

To describe the prevalence of CAD in patients ≤40 years old in Galicia

To describe the prevalence of CAD in patients ≤40 years old in Galicia

Time frame
15 years

Secondary outcomes

1

To evaluate the influence of PM2.5 and PM10 particles on the early manifestation of CAD.

The study will measure the levels of PM2.5, PM10 in patients ≤40 years old with a clinical diagnosis of coronary artery disease and in patients without a diagnosis of coronary artery disease, in order to compare the differences.

Time frame
15 years
2

To describe the prevalence of ozone (O3), nitrogen dioxide (NO2), sulfur dioxide (SO2), benzene (C6H6), carbon monoxide (CO), and heavy metals such as arsenic, cadmium, nickel, and lead in the premature manifestation of CAD.

To describe the prevalence of ozone (O3), nitrogen dioxide (NO2), sulfur dioxide (SO2), benzene (C6H6), carbon monoxide (CO), and heavy metals such as arsenic, cadmium, nickel, and lead in the premature manifestation of CAD.

Time frame
15 years
3

To determine the correlation of noise pollution with premature CAD by age and sex.

To determine the correlation of noise pollution with premature CAD by age and sex.

Time frame
15 years
4

To identify the impact of temperatures on early CAD by age and sex.

The study will determine the impact of extreme temperatures, both heat and cold, on the premature presentation of coronary artery disease, by comparing this exposure between patients with and without the disease and sex.

Time frame
15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

pablo Juan-Salvadores

Lead sponsor

Fundacin Biomedica Galicia Sur

Sponsor institution

Fundacin Biomedica Galicia Sur

Collaborator

Conselleria de Saúde Pública de Galicia

Collaborator

Conselleria de Medio Ambiente, Territorio e Vivenda de Galicia

Collaborator