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

Recruiting

• Conditions: Coronary Artery Disease Premature; MINOCA; Myocardial Infarction; Angina, Stable; Acute Coronary Syndrome

• Registration Number: NCT06464042
• Lead Sponsor: pablo Juan-Salvadores

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-23
• Status Verified: 2024-06
• Study First Submitted: 2024-06-03
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4272

Inclusion Criteria

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

Exclusion Criteria

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

CONTROL

Inclusion Criteria:

• 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

Exclusion Criteria:

• Present with non-ischemic coronary diseas.
• Have a serious condition that affects or decreases life expectancy.
• Do not have a postal code or primary care center assigned in their medical records in Galicia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	15 years	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 determine the differences in exposure to environmental pollutants in patients ≤40 years old with and without coronary artery disease	15 years	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.
To describe the prevalence of CAD in patients ≤40 years old in Galicia	15 years	To describe the prevalence of CAD in patients ≤40 years old in Galicia

Secondary Outcome Measures

Name	Time	Method
To determine the correlation of noise pollution with premature CAD by age and sex.	15 years	To determine the correlation of noise pollution with premature CAD by age and sex.
To identify the impact of temperatures on early CAD by age and sex.	15 years	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.
To compare the effect of environmental pollutants and their relationship with CAD between men and women.	15 years	The influence of different environmental pollutants on the premature presentation of coronary artery disease will be analyzed, taking into account the differences between women and men.
To evaluate the influence of PM2.5 and PM10 particles on the early manifestation of CAD.	15 years	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.
To evaluate the incidence of serious adverse events	15 years	To evaluate the incidence of recurrent myocardial infarction, revascularizations (unplanned after admission), stroke, death, major bleeding (BARC scale 2 or higher), hospital admission for stable angina, unstable angina, acute coronary syndrome with or without ST elevation, congestive heart failure (CHF), or heart transplant during 1, 5, and 10 years. By age and sex.
To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).	15 years	To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).
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.	15 years	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.

Trial Locations

Locations (1)

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain