NCT07301489Recruiting
Akershus Cardiac Examination (ACE) 5 Study
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
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- University Hospital, Akershus
- Diseases
- Lung cancer
- NCT number
- NCT07301489
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 1 Oct 2025 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior history of lung cancer, renal cancer, melanoma or breast cancer
- 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
- 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
Other illness
- Psychiatric or other disorders that are incompatible with compliance to the protocol requirements and follow-up
Other
- Recent abnormal pulmonary findings under work-up of standard care
- Having had chest CT \<1 year before potential entry into the study
- Inability to provide signed informed consent
- Insufficient understanding of the languages in which trial information is available
- Unable to be followed-up for at least 5-years
- Body weight \>140 Kg because of difficulty of conducting the CT exam
- Patients unwilling or unable to comply with the protocol
Who the study is looking for
- 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
- 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
Age in the registry: 60 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.