Akershus Cardiac Examination (ACE) 5

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Akershus University Hospital
  Lørenskog, Akershus, Norway Recruiting

Study contacts

• Study coordinator: Helge Røsjø, MD, PhD
• Email: helge.rosjo@medisin.uio.no
• Phone: +4791545864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.