Akershus Cardiac Examination (ACE) 5 Study

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.

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.

Sponsors & Collaborators

• Uppsala University Hospital

  collaborator OTHER

• University Hospital, Akershus

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2028-11-30

Completion

2041-04-30

Countries

• Norway