EQ-5D-5L value set for Norway: a hybrid model using cTTO and DCE data.
Andrew M Garratt, Knut Stavem, James W Shaw...
https://pubmed.ncbi.nlm.nih.gov/39565555Actively Recruiting
Phase Not Applicable
Age: 60Years - 79Years
All Genders
ID07301489
Akershus Cardiac Examination (ACE) 5 Study: Lung Cancer Screening Plus Program to Improve Cardiovascular Risk Profile and Health in Heavy Smokers
Led by University Hospital, Akershus · Updated on 2025-12-24
1000
Participants Needed
1
Research Sites
647 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Akershus
Lead Sponsor
U
Uppsala University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve cardiovascular health in individuals with a heavy smoking history by adding cardiovascular disease (CVD) prevention to lung cancer screening programs. Smoking increases the risk of dying prematurely, mainly from cardiovascular disease and lung cancer. The study focuses on detecting early signs of coronary artery disease using chest CT scans originally done for lung cancer screening, and then evaluating a follow-up program to reduce cardiovascular risk in these high-risk individuals. Participants will be randomly assigned to one of two groups. The intervention group will receive a hospital-based, nurse-led follow-up program that includes risk assessment and management of cardiovascular risk factors such as smoking cessation, blood pressure, cholesterol, and blood sugar control. Participants usually meet with a nurse twice during 12 months, with additional doctor visits if needed, and receive guidance on medications and lifestyle changes. The control group will continue with standard care led by their general practitioners. During the study, participants will undergo baseline assessments including blood sampling and CT scan evaluations. Follow-up visits will monitor their cardiovascular risk profile, adherence to treatment goals, and health status over 12 months. The main outcome is whether participants reach treatment goals or start new guideline-directed therapies for cardiovascular risk factors. Secondary outcomes include medication use, smoking status, blood tests, blood pressure, physical activity, quality of life, and longer-term cardiovascular events. The total study duration extends up to 15 years for some outcomes.
CONDITIONS
Brief Title
Akershus Cardiac Examination (ACE) 5 Study
Who Can Participate
Age: 60Years - 79Years
All Genders
Eligibility Criteria
You may qualify if you...
- Women and men aged 60 to 79 years old (inclusive)
- Smoking history of at least 35 pack-years
- Current smoker or quit smoking less than 10 years ago, or high lung cancer risk based on PLCOm2012 model
- Willing and able to comply with scheduled visits, tests, and procedures
- Signed written informed consent
- Affiliated to a social security system
- Participants from the TIDL Study with available non-contrast, non-cardiac chest CT images
- Signed consent for cardiovascular add-on study and agree to 1-year follow-up visit
You will not qualify if you...
- Recent abnormal lung findings under standard care work-up
- Chest CT done less than 1 year before potential study entry
- Current or previous lung cancer, renal cancer, melanoma, or breast cancer
- Unable to provide informed consent or insufficient understanding of study languages
- Psychiatric or other disorders incompatible with study compliance
- Unable to be followed for at least 5 years
- Body weight over 140 kg
- Any medical or surgical condition, including short life expectancy, impairing study participation
- Unwilling or unable to comply with protocol
- History of non-compliance to medical management or unreliable patient
- History or evidence of alcohol or drug abuse within last 12 months affecting participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Characterization
Duration - Up to 1 day
Participants undergo baseline assessments including blood sampling, calculation of cardiovascular risk scores, and evaluation of coronary artery calcification using non-contrast, non-cardiac chest CT scans obtained from prior lung cancer screening.
1 baseline visit (in-person)
Intervention or Standard Care Follow-up
Duration - 12 months
Participants are randomized into two groups: one receives hospital-based, nurse-led follow-up including risk stratification and risk factor intervention with typically two nurse visits and additional physician visits as needed over 12 months; the other group receives follow-up care from their General Practitioner according to current standard practice.
Typically 2 hospital visits with study nurse and additional visits with study physician as needed, or regular General Practitioner visits depending on group assignment
Follow-up Assessment
Duration - 1 day for primary follow-up; extended long-term monitoring up to 15 years
After 12 months, participants complete follow-up assessments to evaluate cardiovascular risk profile changes, including treatment goals for smoking cessation, lipid levels, blood pressure, and HbA1c. Additional long-term monitoring of cardiovascular events and mortality may occur up to 15 years post-baseline.
1 follow-up visit at 12 months (in-person); long-term monitoring with periodic data collection
Trial Site Locations
Total: 1 location
1
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Actively Recruiting
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Research Team
H
Helge Røsjø, MD, PhD
M
Magnus N Lyngbakken, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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Published Research Related To This Trial
2024 ESC Guidelines for the management of chronic coronary syndromes.
Christiaan Vrints, Felicita Andreotti, Konstantinos C Koskinas...
https://pubmed.ncbi.nlm.nih.gov/39210710Challenges in coronary heart disease prevention - experiences from a long-term follow-up study in Norway.
E Sverre, K Peersen, J Perk...
https://pubmed.ncbi.nlm.nih.gov/33274648The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART).
Tomas Jernberg, Mona F Attebring, Kristina Hambraeus...
https://pubmed.ncbi.nlm.nih.gov/208017802021 ESC Guidelines on cardiovascular disease prevention in clinical practice.
Frank L J Visseren, François Mach, Yvo M Smulders...
https://pubmed.ncbi.nlm.nih.gov/34458905Prevalence of atrial fibrillation and cardiovascular risk factors in a 63-65 years old general population cohort: the Akershus Cardiac Examination (ACE) 1950 Study.
Trygve Berge, Magnus Nakrem Lyngbakken, Håkon Ihle-Hansen...
https://pubmed.ncbi.nlm.nih.gov/30068617SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe.
SCORE2 working group and ESC Cardiovascular risk collaboration
https://pubmed.ncbi.nlm.nih.gov/341201772016 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.
Harvey S Hecht, Paul Cronin, Michael J Blaha...
https://pubmed.ncbi.nlm.nih.gov/27916431The National Lipid Association scientific statement on coronary artery calcium scoring to guide preventive strategies for ASCVD risk reduction.
Carl E Orringer, Michael J Blaha, Ron Blankstein...
https://pubmed.ncbi.nlm.nih.gov/33419719ACCF/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.
Philip Greenland, Robert O Bonow, Bruce H Brundage...
https://pubmed.ncbi.nlm.nih.gov/17239724