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

NCT06464042 | Recruiting

• 3 other identifiers: AirHeart StudySEC/FEC-INV-CLI 23/23CI23-06
• Study Type: observational
• Target: 4,272
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Air pollution; young; Coronary Artery Disease Premature

Outcome Measures

Primary Outcomes (3)

• 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.

  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 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 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

  15 years

Secondary Outcomes (7)

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

  15 years

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

  15 years

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

  15 years

• To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).

  15 years

Study Arms (2)

Premature Coronary Artery Disease

Patients between 18 and 40 years old diagnosed with coronary artery disease, including: ST-elevation myocardial infarction (STEMI), non-ST-elevation acute coronary syndrome (NSTE-ACS), unstable angina, stable angina, MINOCA or silent angina

Non Coronary Artery Disease

Patient without coronary artery disease For each case, 3 controls matched by age (±1 year), sex, postal code, and/or primary care center will be included. To avoid the selection of controls that could be associated with an overestimation of exposure to cardiovascular risk factors, the controls will be recruited from the preoperative unit and selected from subjects who have undergone minor clinical procedures (vasectomy, hernia repair, phimosis, prominent ear correction, tubal ligation, euthyroid thyroid nodule, plastic surgery, lipomas, vocal cord cysts, among others), or from the trauma service, selecting those attending for fractures or sprains. This approach ensures a complete medical history along with analytical values in their electronic medical records

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• Not having a postal code and primary care center assigned in their medical records in Galicia
• CONTROL
• 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.
• Do not have a postal code or primary care center assigned in their medical records in Galicia

Sponsors & Collaborators

• pablo Juan-Salvadores: lead
• Fundacin Biomedica Galicia Sur: collaborator
• Conselleria de Saúde Pública de Galicia: collaborator
• Conselleria de Medio Ambiente, Territorio e Vivenda de Galicia: collaborator

Study Sites (1)

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36211, Spain

RECRUITING

Related Publications (7)

• Juan-Salvadores P, Veiga C, Jimenez Diaz VA, Guitian Gonzalez A, Iglesia Carreno C, Martinez Reglero C, Baz Alonso JA, Caamano Isorna F, Romo AI. Using Machine Learning Techniques to Predict MACE in Very Young Acute Coronary Syndrome Patients. Diagnostics (Basel). 2022 Feb 6;12(2):422. doi: 10.3390/diagnostics12020422.

  PMID: 35204511 BACKGROUND

• Juan-Salvadores P, Jimenez Diaz VA, Iglesia Carreno C, Guitian Gonzalez A, Veiga C, Martinez Reglero C, Baz Alonso JA, Caamano Isorna F, Iniguez Romo A. Coronary Artery Disease in Very Young Patients: Analysis of Risk Factors and Long-Term Follow-Up. J Cardiovasc Dev Dis. 2022 Mar 11;9(3):82. doi: 10.3390/jcdd9030082.

  PMID: 35323630 BACKGROUND

• Juan-Salvadores P, Jimenez Diaz VA, Rodriguez Gonzalez de Araujo A, Iglesia Carreno C, Guitian Gonzalez A, Veiga Garcia C, Baz Alonso JA, Caamano Isorna F, Iniguez Romo A. Clinical Features and Long-Term Outcomes in Very Young Patients with Myocardial Infarction with Non-Obstructive Coronary Arteries. J Interv Cardiol. 2022 Jul 30;2022:9584527. doi: 10.1155/2022/9584527. eCollection 2022.

  PMID: 35990214 BACKGROUND

• Chen R, Yin P, Meng X, Liu C, Wang L, Xu X, Ross JA, Tse LA, Zhao Z, Kan H, Zhou M. Fine Particulate Air Pollution and Daily Mortality. A Nationwide Analysis in 272 Chinese Cities. Am J Respir Crit Care Med. 2017 Jul 1;196(1):73-81. doi: 10.1164/rccm.201609-1862OC.

  PMID: 28248546 RESULT

• Orellano P, Reynoso J, Quaranta N, Bardach A, Ciapponi A. Short-term exposure to particulate matter (PM10 and PM2.5), nitrogen dioxide (NO2), and ozone (O3) and all-cause and cause-specific mortality: Systematic review and meta-analysis. Environ Int. 2020 Sep;142:105876. doi: 10.1016/j.envint.2020.105876. Epub 2020 Jun 23.

  PMID: 32590284 RESULT

• Kirwa K, Szpiro AA, Sheppard L, Sampson PD, Wang M, Keller JP, Young MT, Kim SY, Larson TV, Kaufman JD. Fine-Scale Air Pollution Models for Epidemiologic Research: Insights From Approaches Developed in the Multi-ethnic Study of Atherosclerosis and Air Pollution (MESA Air). Curr Environ Health Rep. 2021 Jun;8(2):113-126. doi: 10.1007/s40572-021-00310-y.

  PMID: 34086258 RESULT

• Chen SY, Hwang JS, Chan CC, Wu CF, Wu C, Su TC. Urban Air Pollution and Subclinical Atherosclerosis in Adolescents and Young Adults. J Adolesc Health. 2022 Aug;71(2):233-238. doi: 10.1016/j.jadohealth.2022.03.004. Epub 2022 May 7.

  PMID: 35537887 RESULT

Related Links

• Video

MeSH Terms

Conditions

Angina, Stable; Acute Coronary Syndrome; MINOCA; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Pablo Juan-Salvadores, Pharma, PhD

  Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pablo Juan-Salvadores, Pharma, PhD

CONTACT

+34986825564; pablo.juan@iisgaliciasur.es

Victor A Jiménez-Diaz, MD, MPH

CONTACT

+34986825564; victor.alfonso.jimenez.diaz@sergas.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 18, 2024
• Study Start: May 23, 2024
• Primary Completion: December 31, 2024
• Study Completion: July 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)