Impact of Lifetime Exposure to Air and Noise Pollution on Cardiovascular Disease and Mortality - the AIRCARD Study.

NCT04353232 | Active Not Recruiting

• 1 other identifier: AIRCARD
• Study Type: observational
• Target: 33,723
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Particulate Matter Inhalation Injury; Arteriosclerosis; Pollution; Exposure

Keywords

Air Pollution; Environmental Exposure; DANCAVAS; VIVA; DEHM/UBN/AirGIS; Noise Pollution

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Study Arms (2)

DANCAVAS trial

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.

VIVA trial

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.

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men aged 60-74 from DANCAVAS and VIVA trials

You may qualify if:

• \- male gender, age between 60-74 years living on the Island of Funen, or in the surrounding communities of Vejle, Silkeborg and Nykøbing Falster.

You may not qualify if:

• VIVA study
• \- male gender, age between 65-74 years living in the region of Mid Denmark (Viborg County).

Sponsors & Collaborators

• Odense University Hospital: lead
• DANCAVAS Study Group: collaborator
• Department of Environmental Science, Aarhus: collaborator
• Department of Cardiac, Thoracic and Vascular Surgery, Odense University Hospital: collaborator
• Department of Cardiology, Odense University Hospital: collaborator
• Danish Cancer Society: collaborator

Study Sites (1)

Cardiovascular Research Unit - OUH Svendborg

Svendborg, 5700, Denmark

Location

Related Publications (1)

• 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.

  PMID: 40403531 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Arteriosclerosis

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stephan P Mayntz, MD, MPH

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Jess Lambrechtsen, Prof., MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Roda A Mohamed, MD

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD, Head of Research

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: January 2, 2020
• Primary Completion: January 1, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

DK (1)