AIRCARD
Air and Noise Pollution Exposure and Cardiovascular Disease in Danish Males Aged 60-74 From DANCAVAS and VIVA: A Population-Based Study.
Sponsor study identifier
observational
33,723
1 country
1
Study Start
January 2, 2020
Actual (reported)Primary Completion
January 1, 2022
Actual (reported)Study Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine the impact of individually lifetime accumulated exposure to air and noise pollution on the incidence and prevalence of cardiovascular diseases (CVD) and mortality. Air as well as noise pollution have harmful effects on human health. Experimental and clinical studies have shown a strong impact between particulate matter (PM2.5) and cardiovascular disease (CVD). Prolonged exposure to PM2.5 has been associated with the development of atherosclerosis and adverse cardiovascular events. However, also short-term exposure has been linked to acute coronary events. PM2.5 is, however, a combination of many components of specific pollutants that have a size of two and a half microns or less in width. However, there is a knowledge gap, as investigation into which specific components of air pollutants that contribute the most to the development of CVD is lacking. There is a need to adopt and encourage preventive measures but also put in place environmental policies that are effective in promoting the reduction of exposure to pollutants. We want to aid in this shift by showing which specific pollutants contribute the most to the development of CVD so that we can better target these specific air pollutants for better prevention initiatives.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2020
Actual (reported)April 15, 2020
Actual (reported)April 20, 2020
Actual (reported)January 1, 2022
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Subclinical and Clinical CVD events, CVD-specific mortality, all-cause mortality
The amount of accumulated air as well as noise pollution as an independent significant risk factor for clinical CVD and mortality, when accounting for all traditional cardiovascular risk factors.
40 years
Maximal infrarenal aortic diameter in mm and presence of abdominal aortic Aneurisme (Yes/N0)
Aortic abdominal aneurism
40 years
Coronary artery calcium (CAC)
the total amount of calcium in the coronary artery
40 years
We performed a population-based, parallel-group, randomized, controlled trial involving men 65 to 74 years of age living in 15 Danish municipalities. The participants were randomly assigned in a 1:2 ratio to undergo screening (the invited group) or not to undergo screening (the control group) for subclinical cardiovascular disease. Randomization was based on computer-generated random numbers and stratified according to municipality. A total of 46,611 participants underwent randomization. After exclusion of 85 men who had died or emigrated before being invited to undergo screening, there were 16,736 men in the invited group and 29,790 men in the control group; 10,471 of the men in the invited group underwent screening (62.6%). In intention-to-treat analyses, after a median follow-up of 5.6 years, 2106 men (12.6%) in the invited group and 3915 men (13.1%) in the control group had died.
In this randomised controlled trial, we randomly allocated (1:1) all men aged 65-74 years living in the Central Denmark Region to screening for abdominal aortic aneurysm, peripheral arterial disease, and hypertension, or to no screening. We based allocation on computer-generated random numbers from 1 to 100 in blocks of 1067 to 4392, stratified by 19 municipalities. Only the non-screening group and the investigator assessing outcomes were masked. We invited participants who were found to have abdominal aortic aneurysm or peripheral arterial disease back for confirmation and eventual initiation of relevant pharmacological therapy. We further offered participants with abdominal aortic aneurysm annual control or surgical repair. We referred participants with suspected hypertension to their general practitioner. The primary outcome was all-cause mortality, assessed 5 years after randomisation. This trial is registered at ClinicalTrials.gov, number NCT00662480.
Men aged 60-74 from DANCAVAS and VIVA trials
Cardiovascular Research Unit - OUH Svendborg
Svendborg, 5700, Denmark
Mayntz SP, Mohamed RA, Mejldal A, Moller JK, Lindholt JS, Diederichsen AC, Frohn LM, Brandt J, Ketzel M, Khan J, Lambrechtsen J. Long-Term Road Traffic Noise, Air Pollution, and Cardiovascular Disease: AIRCARD: A Prospective Cohort Study. JACC Adv. 2025 Jun;4(6 Pt 1):101787. doi: 10.1016/j.jacadv.2025.101787. Epub 2025 May 21.
Mayntz SP, Mohamed RA, Mejldal A, Moller JK, Lindholt JS, Diederichsen ACP, Frohn LM, Lambrechtsen J. Statistical Analysis Plan for the AIRCARD Study: Individual Long-Term Air and Noise Pollution Exposure and Cardiovascular Disease Incidence and Mortality - A Prospective Cohort Study Utilizing DANCAVAS and VIVA Screening Trials. Cardiology. 2025;150(1):56-62. doi: 10.1159/000539459. Epub 2024 Jul 17.
Stephan P Mayntz, MD, MPH
Odense University Hospital
Jess Lambrechtsen, Prof., MD
Odense University Hospital
Roda A Mohamed, MD
Odense University Hospital
33,723 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2020
First Posted
April 20, 2020
Study Start
January 2, 2020
Actual (reported)The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Measures of blod pressure on the ankle in mmHg and brachial in mmHg to determined periferal arterial disease (PAD)
lowest measured ankle brachial blood pressure index or presence of PAD
40 years
Contact the study team to confirm eligibility.
Primary Completion
January 1, 2022
Actual (reported)Study Completion
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 24, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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