Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
1000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-10-01
Study Completion Date
2041-04-30
Brief Summary
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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.
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.
Detailed Description
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Background - The pathophysiology of chronic coronary syndrome
Myocardial infarction is the number 1 cause of death among smokers. An underlying framework related to this project is the potential to detect and treat atherosclerotic cardiovascular disease (ASCVD), which primarily manifests as coronary artery disease (CAD), prior to the development of symptoms and clinical events. This is important as CAD could be an unstable condition where acute occlusion of coronary arteries will lead to immediate myocardial necrosis, which is referred to as acute myocardial infarction. Smoking is a principal risk factor for atherosclerotic plaques and later symptomatic CAD. Myocardial infarction has significant mortality, both in the acute phase and later due to post-infarction heart failure mortality as well as recurrent myocardial infarction. As many as 1/5 of all patients having a myocardial infarction experience sudden cardiac death as their first symptom. Strategies that can detect CAD prior to events that leads to symptoms (subclinical disease) is therefore highly desirable.
Background - Lung Cancer Screening Programs and risk stratification for CVD
Lung cancer screening programs represent an excellent opportunity to screen high-risk individuals for ASCVD. Non-contrast, non-cardiac chest CT is the cornerstone of lung cancer screening and performed in all lung cancer screening participants. With these CT scans, the investigators can assess coronary artery calcification (CAC) with acceptable accuracy, either by using the four-group visual score or other method, like calculating Agatston score or ordinal visual scores. Moreover, as contrast agents are not required for the cardiac assessment and there is no need for ECG-triggering or cardiac specific protocols, the CT scans will not represent any risk to participant health or put additional strain on health services performing lung cancer screening. Radiation from current CT scans for lung cancer screening is 1.5-3 mSv, which is below the background radiation.
The clinical value of CACS by both Agatston, ordinal visual scores and the four-group visual score has been demonstrated in several studies, and the investigators believe that specific characteristics of our screening population will make assessing coronary artery calcification especially valuable for identifying subclinical CAD in the ACE 5 Study population. Assessment of CAC is also recommended by the National Lipid Association and the 2016 SCCT/STR guidelines for coronary artery calcium scoring of non-contrast noncardiac chest CT scans. One caveat of using coronary artery calcification to screen for subclinical CAD in the general population has been a very small number of individuals with CACS=0 that still experience cardiovascular events during follow-up. While CAC=0 is considered the one most important negative risk factor, a study of CAC in the lung cancer screening setting with non-contrast noncardiac chest CT scans show that up to 10% of the scans with CAC=0 experienced a major cardiac event. Hence, it is suggested that when CAC is assessed in noncardiac chest CT scans, CAC=0 should not always lead to delayed or avoidance of pharmacotherapies.
Traditional risk models like SCORE 2 also has limitations. Although excellent calibrated in the general population to identify high-risk individuals, SCORE 2 (and other models) cannot separate individual subjects in a group where all met the criteria of intermediate to high risk (\>7.5% risk of cardiovascular event over 10-year follow-up). Hence, in our lung cancer screening population the inclusion criteria of age 60-79 years and 35 pack years of tobacco exposure in the TIDL Study will make most participants in the ACE 5 Study classified as intermediate to high risk for future cardiovascular event. Moreover, from epidemiological studies in the same age group, the investigators found 62% of middle-aged individuals to have a diagnosis of hypertension (defined according to prior, conservative criteria with blood pressure ≥140/90 mmHg) and mean total cholesterol was 5.5 mmol/L12. Accordingly, the investigators recognize that most participants in the ACE 5 Study will be classified as at least intermediate risk for CVD, and that no further separation is possible based on the SCORE 2 risk model.
Strategies to detect and reduce risk factors for ASCVD
Identifying subclinical CAD with the visual four-group classification will only reduce cardiovascular events if one is able to reduce risk factor profile in affected individuals. Several lifestyle and pharmacological interventions are efficient to reduce disease progression in subclinical CVD. Smoking is a principal risk factor and all participants in TIDL have been offered participation in a smoking cessation program. Smoking cessation will be follow-up also in the ACE 5 Study. Additional risk factors for ASCVD include hypertension, elevated atherogenic lipids, type 2 diabetes mellitus (T2DM), and physical inactivity.
The investigators will inform participants randomized to the standard-of-care group of the results from visual four-group classification of coronary artery calcification and the clinical examination. The investigators will provide this information to the physician of the participants randomized to standard care, given that this is approved by the participant. The investigators will include key information about guideline-directed medical goals, which is also the primary endpoint of the ACE 5 Study, in the letter to the participants and relevant physicians in the standard care group. In the control group, the General Practitioner (GP) will decide treatment and activities to reduce risk factors, which is the current model for follow-up of heavy smokers in Norway.
In contrast, for the intervention group the study will test hospital-based, nurse-led follow-up, including risk stratification and risk factor intervention. This model is a copy of the Swedish model for cardiovascular follow-up which is a 12-month hospital-based ("infarkt mottagning), nurse-led ("infarkt sjöterska") follow-up. In the Swedish model, individuals normally meet nurse x 2 and physician x 1 during 12-months of follow-up. In addition, individuals are informed to contact the hospital for all pharmacological prescriptions during the 12-month period. For all patients randomized to the Lung Cancer Screening Plus Program, the research team will perform an individual multidisciplinary assessment using the risk factors of each individual together with SCORE2 and coronary artery calcification to reach a recommendation for preventive measures aimed at lipid and blood sugar modifying therapy, antihypertensive therapy, smoking cessation, and increased physical activity. At every hospital visit, close monitoring of major prevention goals for guideline-directed medical therapy (GDMT) are checked. The nurse will contact the physician if GDMT goals are not met and therapy will be intensified. Health personnel also talk to patients/ participants about symptoms, side effects, and other questions that may affect treatment adherence.
The Swedish model has proven important to increase number of individuals with optimal GDMT, including reporting 1 year after myocardial infarction that 50% of smokers have stopped smoking, 77% have reached blood pressure target, and 60% have reached cholesterol target. In contrast, less than 30% of Norwegian patients have optimal GDMT after myocardial infarction. Still, whether the Swedish model for follow-up can be transferred also to a lung cancer screening program, and whether this model provides superior results to a strong GP-based health system, are currently not known.
Rationale for the Study
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 atherosclerotic cardiovascular disease (CVD), while approximately 5% will die from lung cancer. Lung cancer screening programs are currently being implemented worldwide, while no screening program has been developed for CVD. To utilize lung cancer screening programs as a basis for early detection of subclinical ASCVD in heavy smokers and to implement cost-efficient systems for risk reduction, should therefore be clinically relevant.
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 \[TIDL\]"). Inclusion criteria for the TIDL Study include age 60-79 years and 35 pack years of tobacco exposure. The inclusion criteria will categorize most participants as at least intermediate risk for CVD during the next decade. As non-contrast, non-cardiac chest CT images, obtained during regular lung cancer screening, directly can assess atherosclerotic cardiovascular burden, it is hypothesized that additions to current lung cancer screening programs concomitantly will reduce CVD risk. In short, the ACE 5 Study will invite 1000 heavy smokers for baseline characterization, including blood sampling. After initial examination, calculation of SCORE 2 and visual four-group classification of CAC, the study will randomize (A) 50% of the participants to the intervention group with hospital-based, nurse-led follow-up and (B) 50% of the participants to the control group.
Study objectives
The TIDL Study has examinations of 1000 participants with non-contrast, non-cardiac chest CT and the ACE 5 Study should be able to include approximately 500 participants in each group. Only participants with complete follow-up data after 12 months are eligible for the primary endpoint, and an additional 5-10% drop out for the second visit is to be expected. The total number of participants in each group with complete data for the primary endpoint is expected to be around 450.
Primary endpoint
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.
Study population The ACE 5 Study will enroll a maximum of 1000 participants meeting all inclusion criteria and no exclusion criteria. Only participants that have already consented to participate in the pilot implementation study for lung cancer screening in Norway ("Tidlig oppdagelse av lungekreft \[TIDL\]") are eligible for inclusion in the ACE 5 Study as these individuals have non-contrast, non-cardiac chest CT images available from the lung cancer screening study.
All patients will be thoroughly informed about all aspects of the study and the study team will collect informed, written consent from all study participants. Regardless of the time, at the request by the participant and not already included in a publication, all data collected in the study relating to the particular participant will be terminated.
There will be no restrictions to the diagnostic testing of our study participants, regardless of randomization status in the study. The decision of the patient to participate in the ACE 5 Study will not influence treatment that is offered to the patient at Akershus University Hospital and patients not participating in the study will receive current strategy/ standard care.
Myocardial infarction is the number 1 cause of death among smokers. An underlying framework related to this project is the potential to detect and treat atherosclerotic cardiovascular disease (ASCVD), which primarily manifests as coronary artery disease (CAD), prior to the development of symptoms and clinical events. This is important as CAD could be an unstable condition where acute occlusion of coronary arteries will lead to immediate myocardial necrosis, which is referred to as acute myocardial infarction. Smoking is a principal risk factor for atherosclerotic plaques and later symptomatic CAD. Myocardial infarction has significant mortality, both in the acute phase and later due to post-infarction heart failure mortality as well as recurrent myocardial infarction. As many as 1/5 of all patients having a myocardial infarction experience sudden cardiac death as their first symptom. Strategies that can detect CAD prior to events that leads to symptoms (subclinical disease) is therefore highly desirable.
Background - Lung Cancer Screening Programs and risk stratification for CVD
Lung cancer screening programs represent an excellent opportunity to screen high-risk individuals for ASCVD. Non-contrast, non-cardiac chest CT is the cornerstone of lung cancer screening and performed in all lung cancer screening participants. With these CT scans, the investigators can assess coronary artery calcification (CAC) with acceptable accuracy, either by using the four-group visual score or other method, like calculating Agatston score or ordinal visual scores. Moreover, as contrast agents are not required for the cardiac assessment and there is no need for ECG-triggering or cardiac specific protocols, the CT scans will not represent any risk to participant health or put additional strain on health services performing lung cancer screening. Radiation from current CT scans for lung cancer screening is 1.5-3 mSv, which is below the background radiation.
The clinical value of CACS by both Agatston, ordinal visual scores and the four-group visual score has been demonstrated in several studies, and the investigators believe that specific characteristics of our screening population will make assessing coronary artery calcification especially valuable for identifying subclinical CAD in the ACE 5 Study population. Assessment of CAC is also recommended by the National Lipid Association and the 2016 SCCT/STR guidelines for coronary artery calcium scoring of non-contrast noncardiac chest CT scans. One caveat of using coronary artery calcification to screen for subclinical CAD in the general population has been a very small number of individuals with CACS=0 that still experience cardiovascular events during follow-up. While CAC=0 is considered the one most important negative risk factor, a study of CAC in the lung cancer screening setting with non-contrast noncardiac chest CT scans show that up to 10% of the scans with CAC=0 experienced a major cardiac event. Hence, it is suggested that when CAC is assessed in noncardiac chest CT scans, CAC=0 should not always lead to delayed or avoidance of pharmacotherapies.
Traditional risk models like SCORE 2 also has limitations. Although excellent calibrated in the general population to identify high-risk individuals, SCORE 2 (and other models) cannot separate individual subjects in a group where all met the criteria of intermediate to high risk (\>7.5% risk of cardiovascular event over 10-year follow-up). Hence, in our lung cancer screening population the inclusion criteria of age 60-79 years and 35 pack years of tobacco exposure in the TIDL Study will make most participants in the ACE 5 Study classified as intermediate to high risk for future cardiovascular event. Moreover, from epidemiological studies in the same age group, the investigators found 62% of middle-aged individuals to have a diagnosis of hypertension (defined according to prior, conservative criteria with blood pressure ≥140/90 mmHg) and mean total cholesterol was 5.5 mmol/L12. Accordingly, the investigators recognize that most participants in the ACE 5 Study will be classified as at least intermediate risk for CVD, and that no further separation is possible based on the SCORE 2 risk model.
Strategies to detect and reduce risk factors for ASCVD
Identifying subclinical CAD with the visual four-group classification will only reduce cardiovascular events if one is able to reduce risk factor profile in affected individuals. Several lifestyle and pharmacological interventions are efficient to reduce disease progression in subclinical CVD. Smoking is a principal risk factor and all participants in TIDL have been offered participation in a smoking cessation program. Smoking cessation will be follow-up also in the ACE 5 Study. Additional risk factors for ASCVD include hypertension, elevated atherogenic lipids, type 2 diabetes mellitus (T2DM), and physical inactivity.
The investigators will inform participants randomized to the standard-of-care group of the results from visual four-group classification of coronary artery calcification and the clinical examination. The investigators will provide this information to the physician of the participants randomized to standard care, given that this is approved by the participant. The investigators will include key information about guideline-directed medical goals, which is also the primary endpoint of the ACE 5 Study, in the letter to the participants and relevant physicians in the standard care group. In the control group, the General Practitioner (GP) will decide treatment and activities to reduce risk factors, which is the current model for follow-up of heavy smokers in Norway.
In contrast, for the intervention group the study will test hospital-based, nurse-led follow-up, including risk stratification and risk factor intervention. This model is a copy of the Swedish model for cardiovascular follow-up which is a 12-month hospital-based ("infarkt mottagning), nurse-led ("infarkt sjöterska") follow-up. In the Swedish model, individuals normally meet nurse x 2 and physician x 1 during 12-months of follow-up. In addition, individuals are informed to contact the hospital for all pharmacological prescriptions during the 12-month period. For all patients randomized to the Lung Cancer Screening Plus Program, the research team will perform an individual multidisciplinary assessment using the risk factors of each individual together with SCORE2 and coronary artery calcification to reach a recommendation for preventive measures aimed at lipid and blood sugar modifying therapy, antihypertensive therapy, smoking cessation, and increased physical activity. At every hospital visit, close monitoring of major prevention goals for guideline-directed medical therapy (GDMT) are checked. The nurse will contact the physician if GDMT goals are not met and therapy will be intensified. Health personnel also talk to patients/ participants about symptoms, side effects, and other questions that may affect treatment adherence.
The Swedish model has proven important to increase number of individuals with optimal GDMT, including reporting 1 year after myocardial infarction that 50% of smokers have stopped smoking, 77% have reached blood pressure target, and 60% have reached cholesterol target. In contrast, less than 30% of Norwegian patients have optimal GDMT after myocardial infarction. Still, whether the Swedish model for follow-up can be transferred also to a lung cancer screening program, and whether this model provides superior results to a strong GP-based health system, are currently not known.
Rationale for the Study
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 atherosclerotic cardiovascular disease (CVD), while approximately 5% will die from lung cancer. Lung cancer screening programs are currently being implemented worldwide, while no screening program has been developed for CVD. To utilize lung cancer screening programs as a basis for early detection of subclinical ASCVD in heavy smokers and to implement cost-efficient systems for risk reduction, should therefore be clinically relevant.
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 \[TIDL\]"). Inclusion criteria for the TIDL Study include age 60-79 years and 35 pack years of tobacco exposure. The inclusion criteria will categorize most participants as at least intermediate risk for CVD during the next decade. As non-contrast, non-cardiac chest CT images, obtained during regular lung cancer screening, directly can assess atherosclerotic cardiovascular burden, it is hypothesized that additions to current lung cancer screening programs concomitantly will reduce CVD risk. In short, the ACE 5 Study will invite 1000 heavy smokers for baseline characterization, including blood sampling. After initial examination, calculation of SCORE 2 and visual four-group classification of CAC, the study will randomize (A) 50% of the participants to the intervention group with hospital-based, nurse-led follow-up and (B) 50% of the participants to the control group.
Study objectives
The TIDL Study has examinations of 1000 participants with non-contrast, non-cardiac chest CT and the ACE 5 Study should be able to include approximately 500 participants in each group. Only participants with complete follow-up data after 12 months are eligible for the primary endpoint, and an additional 5-10% drop out for the second visit is to be expected. The total number of participants in each group with complete data for the primary endpoint is expected to be around 450.
Primary endpoint
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.
Study population The ACE 5 Study will enroll a maximum of 1000 participants meeting all inclusion criteria and no exclusion criteria. Only participants that have already consented to participate in the pilot implementation study for lung cancer screening in Norway ("Tidlig oppdagelse av lungekreft \[TIDL\]") are eligible for inclusion in the ACE 5 Study as these individuals have non-contrast, non-cardiac chest CT images available from the lung cancer screening study.
All patients will be thoroughly informed about all aspects of the study and the study team will collect informed, written consent from all study participants. Regardless of the time, at the request by the participant and not already included in a publication, all data collected in the study relating to the particular participant will be terminated.
There will be no restrictions to the diagnostic testing of our study participants, regardless of randomization status in the study. The decision of the patient to participate in the ACE 5 Study will not influence treatment that is offered to the patient at Akershus University Hospital and patients not participating in the study will receive current strategy/ standard care.
Conditions
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Heavy Smokers
Lung Cancer Screening
Cardiovascular Risk Profile
Cardiovascular Disease Prevention
Keywords
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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
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
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.
Primary Study Purpose
SCREENING
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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Lung cancer screening plus
Hospital-based, nurse-led follow-up
Group Type
EXPERIMENTAL
Lung Cancer Screening Plus Program
Intervention Type
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.
Standard of Care
General practitioner-led follow-up
Group Type
OTHER
Standard of Care
Intervention Type
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
* 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
* 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
* 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
* 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
Minimum Eligible Age
60 Years
Maximum Eligible Age
79 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Uppsala University Hospital
OTHER
Sponsor Role
collaborator
University Hospital, Akershus
OTHER
Sponsor Role
lead
Responsible Party
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Helge Rørvik Røsjø
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Akershus University Hospital
Lørenskog, Akershus, Norway
Site Status
RECRUITING
Countries
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Norway
Central Contacts
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Facility Contacts
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Ane Stenset
Role: primary
References
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Garratt AM, Stavem K, Shaw JW, Rand K. EQ-5D-5L value set for Norway: a hybrid model using cTTO and DCE data. Qual Life Res. 2025 Feb;34(2):417-427. doi: 10.1007/s11136-024-03837-3. Epub 2024 Nov 20.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sverre E, Peersen K, Perk J, Husebye E, Gullestad L, Dammen T, Otterstad JE, Munkhaugen J. Challenges in coronary heart disease prevention - experiences from a long-term follow-up study in Norway. Scand Cardiovasc J. 2021 Apr;55(2):73-81. doi: 10.1080/14017431.2020.1852308. Epub 2020 Dec 4.
Reference Type
BACKGROUND
Jernberg T, Attebring MF, Hambraeus K, Ivert T, James S, Jeppsson A, Lagerqvist B, Lindahl B, Stenestrand U, Wallentin L. The Swedish Web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART). Heart. 2010 Oct;96(20):1617-21. doi: 10.1136/hrt.2010.198804. Epub 2010 Aug 27.
Reference Type
BACKGROUND
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24/10475
Identifier Type: OTHER
Identifier Source: secondary_id
REK-ID: 870751
Identifier Type: -
Identifier Source: org_study_id