Akershus Cardiac Examination (ACE) 5 Study

NCT07301489 | Recruiting

• 2 other identifiers: REK-ID: 87075124/10475
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Heavy smokers; Lung cancer screening; Cardiovascular risk profile; Cardiovascular disease prevention; Chronic coronary syndrome; Atherosclerotic cardiovascular disease; Non-contrast, non-cardiac chest CT-based screening; Nurse-led follow-up program

Outcome Measures

Primary Outcomes (1)

• 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

  12 months from the baseline visit

Secondary Outcomes (17)

• Number of people with lipid lowering treatment, antihypertensive treatment and antidiabetic treatment at 12 months

  12 months from the baseline visit

• Prevalence of smoking at 12 months post the baseline visit

  12 months from the baseline visit

• Blood lipid concentrations at 12 months post the baseline visit

  12 months after the baseline visit

• Blood pressure at 12 months post the baseline visit

  12 months after the baseline visit

• HbA1c concentrations at 12 months post the baseline visit

  12 months after the baseline visit

Study Arms (2)

Lung cancer screening plus

EXPERIMENTAL

Hospital-based, nurse-led follow-up

Other: Lung Cancer Screening Plus Program

Standard of Care

OTHER

General practitioner-led follow-up

Other: Standard of Care

Interventions

Lung Cancer Screening Plus Program OTHER

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.

Lung cancer screening plus

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 60 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

RECRUITING

Related Publications (18)

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• Vrints C, Andreotti F, Koskinas KC, Rossello X, Adamo M, Ainslie J, Banning AP, Budaj A, Buechel RR, Chiariello GA, Chieffo A, Christodorescu RM, Deaton C, Doenst T, Jones HW, Kunadian V, Mehilli J, Milojevic M, Piek JJ, Pugliese F, Rubboli A, Semb AG, Senior R, Ten Berg JM, Van Belle E, Van Craenenbroeck EM, Vidal-Perez R, Winther S; ESC Scientific Document Group. 2024 ESC Guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024 Sep 29;45(36):3415-3537. doi: 10.1093/eurheartj/ehae177. No abstract available.

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  PMID: 33274648 BACKGROUND

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  PMID: 20801780 BACKGROUND

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.

  PMID: 34458905 BACKGROUND

• Berge T, Lyngbakken MN, Ihle-Hansen H, Brynildsen J, Pervez MO, Aagaard EN, Vigen T, Kvisvik B, Christophersen IE, Steine K, Omland T, Smith P, Rosjo H, Tveit A. Prevalence of atrial fibrillation and cardiovascular risk factors in a 63-65 years old general population cohort: the Akershus Cardiac Examination (ACE) 1950 Study. BMJ Open. 2018 Aug 1;8(7):e021704. doi: 10.1136/bmjopen-2018-021704.

  PMID: 30068617 BACKGROUND

• SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.

  PMID: 34120177 BACKGROUND

• Hecht HS, Cronin P, Blaha MJ, Budoff MJ, Kazerooni EA, Narula J, Yankelevitz D, Abbara S. 2016 SCCT/STR guidelines for coronary artery calcium scoring of noncontrast noncardiac chest CT scans: A report of the Society of Cardiovascular Computed Tomography and Society of Thoracic Radiology. J Cardiovasc Comput Tomogr. 2017 Jan-Feb;11(1):74-84. doi: 10.1016/j.jcct.2016.11.003. Epub 2016 Nov 10.

  PMID: 27916431 BACKGROUND

• Orringer CE, Blaha MJ, Blankstein R, Budoff MJ, Goldberg RB, Gill EA, Maki KC, Mehta L, Jacobson TA. The National Lipid Association scientific statement on coronary artery calcium scoring to guide preventive strategies for ASCVD risk reduction. J Clin Lipidol. 2021 Jan-Feb;15(1):33-60. doi: 10.1016/j.jacl.2020.12.005. Epub 2020 Dec 11.

  PMID: 33419719 BACKGROUND

• Greenland P, Bonow RO, Brundage BH, Budoff MJ, Eisenberg MJ, Grundy SM, Lauer MS, Post WS, Raggi P, Redberg RF, Rodgers GP, Shaw LJ, Taylor AJ, Weintraub WS; American College of Cardiology Foundation Clinical Expert Consensus Task Force (ACCF/AHA Writing Committee to Update the 2000 Expert Consensus Document on Electron Beam Computed Tomography); Society of Atherosclerosis Imaging and Prevention; Society of Cardiovascular Computed Tomography. ACCF/AHA 2007 clinical expert consensus document on coronary artery calcium scoring by computed tomography in global cardiovascular risk assessment and in evaluation of patients with chest pain: a report of the American College of Cardiology Foundation Clinical Expert Consensus Task Force (ACCF/AHA Writing Committee to Update the 2000 Expert Consensus Document on Electron Beam Computed Tomography) developed in collaboration with the Society of Atherosclerosis Imaging and Prevention and the Society of Cardiovascular Computed Tomography. J Am Coll Cardiol. 2007 Jan 23;49(3):378-402. doi: 10.1016/j.jacc.2006.10.001. No abstract available.

  PMID: 17239724 BACKGROUND

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  PMID: 23756678 BACKGROUND

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  PMID: 17161072 BACKGROUND

• Chiles C, Duan F, Gladish GW, Ravenel JG, Baginski SG, Snyder BS, DeMello S, Desjardins SS, Munden RF; NLST Study Team. Association of Coronary Artery Calcification and Mortality in the National Lung Screening Trial: A Comparison of Three Scoring Methods. Radiology. 2015 Jul;276(1):82-90. doi: 10.1148/radiol.15142062. Epub 2015 Mar 9.

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MeSH Terms

Conditions

Atherosclerosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Helge Røsjø, MD, PhD

CONTACT

+4791545864; helge.rosjo@medisin.uio.no

Magnus N Lyngbakken, MD, PhD

CONTACT

+4793408837; magnus.lyngbakken@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-center, pragmatic randomized controlled trial of a non-pharmacological intervention. The investigators will perform visual four-group classification of coronary artery calcification in all participants from the TIDL Study. All ACE 5 Study participants will be invited to a baseline visit and 1-year follow-up visit. Participants will be randomized 1:1 to a hospital-based, nurse-led follow-up program (Lung Cancer Screening Plus Program) or standard of care after the participant has signed written informed consent.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 24, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): April 1, 2041
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Access Criteria: Only de-identified data (marked with study code) will be shared with national and international collaborators.

Locations

NO (1)