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RECRUITING

NCT07301489

Akershus Cardiac Examination (ACE) 5 Study

Sponsor: University Hospital, Akershus

View on ClinicalTrials.gov

Summary

Individuals with extensive smoking history have 2- to 3-fold increased risk of dying prematurely compared to age- and gender-matched peers. Historical data indicate that 55% of heavy smokers will die from cardiovascular disease (CVD), while approximately 5% will die from lung cancer. Lung cancer screening programs are currently being implemented worldwide, but efforts to reduce also CVD are not included. The research group behind the ACE 5 Study are affiliated with the study team behind the implementation study of lung cancer screening in Norway ("Tidlig oppdagelse av lungekreft \[TIDL\]"). The TIDL Study have performed non-contrast, non-cardiac chest CT-based screening for lung cancer in 1000 individuals. Prior studies have demonstrated that a visual four-group classification of coronary artery calcification using non-contrast, non-cardiac chest CT images provide an easily available, non-invasive surrogate index for subclinical and established chronic coronary syndrome. Accordingly, the 2024 European Society of Cardiology guidelines for chronic coronary syndrome promotes that opportunistic screening for atherosclerotic CVD (ASCVD) should be performed when non-contrast, non-cardiac chest CT images are available ("IIa recommendation"). The investigators will now invite TIDL participants for a second study, the Akershus Cardiac Examination (ACE) 5 Study, which will assess whether intervention also against ASCVD ("Lung Cancer Screening Plus Program") will improve cardiovascular risk profile and cardiovascular health in individuals with heavy smoking history. The ACE 5 Study will be a separate study with separate protocol and consent as the ACE 5 Study will focus on the prevention of CVD in individuals with heavy smoking history as add-on to lung cancer screening. The ACE 5 Study will assess the combined effect of (1) non-contrast, non-cardiac chest CT images as basis for ASCVD detection, and (2) the value of a hospital-based, nurse-led follow-up program to improve cardiovascular risk profile and cardiovascular health in individuals with heavy smoking history. Whether a Lung Cancer Screening Plus Program can improve cardiovascular risk profile and indices of improved cardiovascular health compared to the current strategy/standard in individuals with heavy smoking history is currently not known. The primary endpoint relates to status for cardiovascular risk profile after 1-year follow-up, and the study will use pre-defined cutoffs for the different risk factors based on relevant European Society of Cardiology (ESC) Guidelines, especially the 2021 ESC guidelines for primary prevention and the 2024 ESC guidelines for chronic coronary syndrome.

Official title: Akershus Cardiac Examination (ACE) 5 Study: Pragmatic Randomized Controlled Trial of Lung Cancer Screening Plus Program to Improve Cardiovascular Risk Profile and Health in Individuals With Heavy Smoking History

Key Details

Gender

All

Age Range

60 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2025-10-01

Completion Date

2041-04

Last Updated

2025-12-24

Healthy Volunteers

Conditions

Heavy Smokers Lung Cancer Screening Cardiovascular Risk Profile Cardiovascular Disease Prevention

Interventions

OTHER

Lung Cancer Screening Plus Program

In the intervention group, hospital-based, nurse-led follow-up will be tested, including risk stratification and risk factor intervention. Individuals normally meet a study nurse twice during 12-months of follow-up. If needed, this will be supplemented by meeting with a study physician. Individuals are informed to contact the hospital for all pharmacological prescriptions during the 12-month period.

OTHER

Standard of Care

In the control group, the General Practitioner will decide treatment and activities to reduce risk factors, which is the current model for follow-up of heavy smokers in Norway.

Inclusion Criteria used for the lung cancer screening implementation study/ TIDL Study: * Women and men * Ages 60 to 79 years old (inclusive) * A smoking history of at least 35 pack-years and 1) being a current smoker or a former smoker who quit less than 10 years prior or 2) having a PLCOm2012 model 6-year risk for lung cancer incidence over 2.6%. * Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures * Written informed consent obtained prior to performing any protocol-related procedures * The participant should be affiliated to a social security system Exclusion Criteria used for the lung cancer screening implementation study/ TIDL Study: * Recent abnormal pulmonary findings under work-up of standard care * Having had chest CT \<1 year before potential entry into the study * Current or prior history of lung cancer, renal cancer, melanoma or breast cancer * Inability to provide signed informed consent * Insufficient understanding of the languages in which trial information is available * Psychiatric or other disorders that are incompatible with compliance to the protocol requirements and follow-up * Unable to be followed-up for at least 5-years * Body weight \>140 Kg because of difficulty of conducting the CT exam Inclusion Criteria used for the ACE 5 Study: * Participants from the TIDL Study with non-contrast, non-cardiac chest CT images available as part of the implementation lung cancer screening study * Signed consent for cardiovascular add on-study and agree to protocol, including follow-up visit 1-year after the baseline examination Exclusion Criteria used for the ACE 5 Study: * Any surgical or medical condition, including short life-expectancy, based on medical records or clinical findings prior to randomization, that will impair the ability of the patient to participate in the study * Patients unwilling or unable to comply with the protocol * History of non-compliance to medical management and patients who are considered potentially unreliable, based on information obtained prior to randomization * History or evidence of alcohol or drug abuse with the last 12 months, based on information obtained prior to randomization, that will influence study participation

Locations (1)

Akershus University Hospital

Lørenskog, Akershus, Norway