Akershus Cardiac Examination (ACE) 5
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
NA · University Hospital, Akershus · NCT07301489
This project tests whether using the chest CT scans from lung cancer screening to look for coronary artery calcium can help find hidden heart disease in people aged 60–79 with heavy smoking histories.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 60 Years to 79 Years |
| Sex | All |
| Sponsor | University Hospital, Akershus (other) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Lørenskog, Akershus) |
| Trial ID | NCT07301489 on ClinicalTrials.gov |
What this trial studies
The ACE 5 project uses the low-dose, non-contrast chest CTs performed for lung cancer screening to visually classify coronary artery calcification into four categories as a surrogate for coronary artery disease. Eligible high-risk participants (age 60–79 with heavy smoking histories or elevated PLCOm2012 risk) are offered a Lung Cancer Screening Plus program that incorporates cardiac findings and follow-up alongside standard lung screening, compared with usual care pathways. The study relies on existing imaging without additional cardiac-specific CT, and links CT-based calcium grading to clinical follow-up and prevention strategies. The goal is to integrate cardiovascular risk detection into routine lung screening visits to identify subclinical disease earlier.
Who should consider this trial
Good fit: People aged 60–79 with at least a 35 pack‑year smoking history who currently smoke or quit within the past 10 years (or who meet the PLCOm2012 6‑year risk threshold) and who can provide informed consent and attend screening visits.
Not a fit: People outside the age or smoking-risk criteria, those with recent chest CTs, active or recent qualifying cancers, inability to consent, or who cannot attend the Akershus site are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this could enable earlier detection and treatment of coronary artery disease in heavy smokers, potentially reducing heart attacks and cardiovascular deaths.
How similar studies have performed: Prior studies have shown that coronary artery calcium grading on non-contrast chest CT correlates with coronary disease risk and can be read reliably in lung screening cohorts, though integrating it into preventive care pathways is still being implemented.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lørenskog, Akershus
- Akershus University Hospital — Lørenskog, Akershus, Norway (RECRUITING)
Study contacts
- Study coordinator: Helge Røsjø, MD, PhD
- Email: helge.rosjo@medisin.uio.no
- Phone: +4791545864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heavy Smokers, Lung Cancer Screening, Cardiovascular Risk Profile, Cardiovascular Disease Prevention, Heavy smokers, Lung cancer screening, Cardiovascular risk profile, Cardiovascular disease prevention