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.
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
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
Parallel
Lung Cancer Screening Plus Program
Other interventionIn 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.
Standard of Care
Other interventionIn 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.
Number of people reaching treatment goals or started new GDMT for smoking, lipid concentrations, blood pressure, and HbA1c
To determine whether a Lung Cancer Screening Plus Program in individuals with heavy smoking history improves cardiovascular risk profile, defined as reaching treatment goals or started new GDMT for smoking, lipid concentrations, blood pressure, and HbA1c, compared to the current strategy/standard care. Treatment targets are defined as following: 1. LDL cholesterol \< 1.4 or started treatment with statin and/or ezetimibe after baseline visit 2. Blood pressure \<130/80 or started new antihypertensive therapy after baseline visit 3. No smoking 4. HbA1c \< 52 mmol/L or started new antidiabetic therapy after baseline visit
Number of people with lipid lowering treatment, antihypertensive treatment and antidiabetic treatment at 12 months
To estimate change in lipid lowering treatment, antihypertensive treatment and antidiabetic treatment 12 months after the baseline visit for participants in the Lung Cancer Screening Plus Program compared to current strategy/ standard care in individuals with heavy smoking history
Prevalence of smoking at 12 months post the baseline visit
To estimate change in smoking prevalence at 12 months post the baseline visit for participants in the Lung Cancer Screening Plus Program compared to current strategy/ standard care in individuals with heavy smoking history
Blood lipid concentrations at 12 months post the baseline visit
To estimate change in blood lipid concentrations at 12 months post the baseline visit for participants in the Lung Cancer Screening Plus Program compared to current strategy/ standard care in individuals with heavy smoking history
Blood pressure at 12 months post the baseline visit
To estimate change in blood pressure at 12 months post the baseline visit for participants in the Lung Cancer Screening Plus Program compared to current strategy/ standard care in individuals with heavy smoking history
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University Hospital, Akershus
Lead sponsor
Uppsala University Hospital
Collaborator
