Coronary Artery Disease PrematureAIRHEARTNCT06464042
Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease
An observational study of Coronary Artery Disease Premature and Angina, Stable, run by pablo Juan-Salvadores at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Coronary Artery Disease Premature, Angina, Stable, Acute Coronary Syndrome
- How many people
- 4,272 participants
- Where
- 1 siteSpain
- Study dates
- 23 May 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Women and men between 18 and 40 years old with a diagnosis of coronary artery disease coded 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
Who cannot join
- Not having a postal code and primary care center assigned in their medical records in Galicia
- CONTROL
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36211
Pablo Juan Salvadores, MPH,PhD, +34986825564, pablo.juan@iisgaliciasur.es
Victor A Jiménez Díaz, MD
About this study
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
- Medical subject headings
- Angina, Stable, Acute Coronary Syndrome, MINOCA, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 15 years
Secondary outcomes (7)
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.
Measured: 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.
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.
Measured: 15 years
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.
Measured: 15 years
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.
Measured: 15 years
To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).
To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).
Measured: 15 years
To compare the effect of environmental pollutants and their relationship with CAD between men and women.
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.
Measured: 15 years
To evaluate the incidence of serious adverse events
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start23 May 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Disease PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pablo Juan-Salvadores
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacin Biomedica Galicia Sur, Conselleria de Saúde Pública de Galicia, Conselleria de Medio Ambiente, Territorio e Vivenda de Galicia
- Responsible party
- Sponsor-investigator, pablo Juan-Salvadores, Fundacin Biomedica Galicia Sur
- Investigators
- Pablo Juan-Salvadores, Pharma, PhD, Principal investigator, Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464042
- Sponsor's protocol ID
- AirHeart Study
- Other IDs
- SEC/FEC-INV-CLI 23/23, CI23-06
- Acronym
- AIRHEART
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35204511Juan-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.
PubMed 35323630Juan-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.
PubMed 35990214Chen 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.
PubMed 28248546Orellano 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.
PubMed 32590284Kirwa 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.
PubMed 34086258Chen 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.
PubMed 35537887
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Air Quality on the Development and Progression of Premature Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06464042
- Acronym / sponsor ID
- AIRHEART / AirHeart Study
- Conditions
- Coronary Artery Disease Premature, Angina, Stable, Acute Coronary Syndrome, MINOCA, Myocardial Infarction
- Keywords
- Air pollution, young, Coronary Artery Disease Premature
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,272 participants (estimated)
- Lead sponsor
- pablo Juan-SalvadoresUniversity, hospital or other
- Collaborators
- Fundacin Biomedica Galicia Sur, Conselleria de Saúde Pública de Galicia, Conselleria de Medio Ambiente, Territorio e Vivenda de Galicia
- Study start
- 23 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Women and men between 18 and 40 years old with a diagnosis of coronary artery disease coded 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
Key exclusion criteria (5 listed)
- Not having a postal code and primary care center assigned in their medical records in Galicia
- CONTROL
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the differences in exposure to environmental pollutants in patients ≤40 years old with and without coronary artery disease
Time frame: 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 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
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 describe the prevalence of CAD in patients ≤40 years old in Galicia
Time frame: 15 years
To describe the prevalence of CAD in patients ≤40 years old in Galicia
7 secondary outcomes
To evaluate the influence of PM2.5 and PM10 particles on the early manifestation of CAD.
Time frame: 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.
Time frame: 15 years
To determine the correlation of noise pollution with premature CAD by age and sex.
Time frame: 15 years
To identify the impact of temperatures on early CAD by age and sex.
Time frame: 15 years
To determine the correlation of environmental pollutants in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA).
Time frame: 15 years
To compare the effect of environmental pollutants and their relationship with CAD between men and women.
Time frame: 15 years
To evaluate the incidence of serious adverse events
Time frame: 15 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Background: PubMed 35204511Juan-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.
- Background: PubMed 35323630Juan-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.
- Background: PubMed 35990214Juan-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.
- Results publication: PubMed 28248546Chen 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.
- Results publication: PubMed 32590284Orellano 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.
- Results publication: PubMed 34086258Kirwa 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.
- Results publication: PubMed 35537887Chen 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.
- VideoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Juan-Salvadores, Pharma, PhD principal investigator
Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease Premature and Angina, Stable, run by pablo Juan-Salvadores at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo Juan-Salvadores, Pharma, PhD (+34986825564, pablo.juan@iisgaliciasur.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the differences in exposure to environmental pollutants in patients ≤40 years old with and without coronary artery disease (time frame: 15 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06464042, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.