SmokingPhase 4CAROSSNCT00548665
Carotid Plaque Screening Trial in Smokers
A Phase 4 study testing Carotid ultrasound for plaque screening and Brief advice for smoking cessation in people with Smoking, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine the impact of carotid plaque screening on smoking cessation and control of other cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Carotid ultrasound for plaque screening and Brief advice for smoking cessation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2007to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current daily smoker with more or equal to 10 cigarettes per day for at least 1 year
- Age between 40 and 70 years
Who cannot join
- Prevalent CVD at baseline, defined as a medical diagnosis or self-report of coronary heart disease, stroke or transient ischemic attack, peripheral arterial disease, carotid artery disease, congestive heart failure, or having a pacemaker.
- Unstable life-threatening or severe medical conditions (major arrhythmia, cancer,…)
- Current psychiatric disease
- Current substance abuse (cannabis, other drugs, alcohol abuse)
- Current use of pharmacological agent to quit smoking
- Current participation in another clinical trial
Show all 10Show fewer
- Plan to move out of the French part of Switzerland in the following year
- Recent carotid ultrasound (< 1 year) to assess subclinical CVD
- Language barrier (not fluent with French)
- Potential difficulty to obtain good imaging of the carotid by ultrasound: past radiotherapy or major surgery of the neck
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Carotid Plaque Screening on Smoking Cessation and Control of Other Cardiovascular Risk Factors: A Randomized Controlled Trial.
The purpose of this study is to determine the impact of carotid plaque screening on smoking cessation and control of other cardiovascular risk factors.
Read the detailed description
Tobacco smoking is highly prevalent in Switzerland (31% of adults), and 50% of smokers die from a tobacco-related disease, mainly cardiovascular disease (CVD). The smoking prevalence makes the evaluation of new strategies for smoking cessation a crucial priority.
The presence of plaques of atherosclerosis ("cholesterol" deposits in the artery wall), as measured by carotid ultrasound, increases the risk of future CVD. The use of plaque screening to motivate patients to improve smoking cessation has received little attention. In one study, screening for atherosclerotic plaques increased the self-reported rates of smoking cessation, but without biochemical validation of cessation and these smokers had only low nicotine dependence. Moreover, no trial has examined the impact of plaque screening on the control of other cardiovascular risk factors.
We now propose a randomized controlled trial of carotid plaque screening in 530 regular smokers aged 40-70 years, recruited from the community, to measure the impact of plaque screening on smoking cessation(main outcome) and control of other cardiovascular risk factors (secondary outcomes) after 1-year follow-up. Secondary outcomes are low-density lipoprotein cholesterol, hemoglobin A1C (if diabetes), high-sensitivity C-reactive protein and blood pressure. Smokers will all receive advice for smoking cessation and, then, will be randomly assigned to either the intervention group (with plaque screening) or the control group (without plaque screening). Smokers with one or more carotid plaque will receive pictures of their own plaques with a standardized explanation. To ensure equal contact conditions, smokers not undergoing ultrasound or without plaque will receive a standardized explanation on the risks of tobacco smoking.
This study is innovative because plaque screening is a promising and increasingly used strategy to motivate patients to stop smoking and improve control of cardiovascular risk factors, but its effectiveness has been poorly studied. Successful completion of this project will provide a strong scientific basis for using this strategy for smoking cessation and control of cardiovascular risk factors. If testing is not an effective tool, such testing might represent an important waste of expenditure, and healthcare expenditures should be used for other strategies. Given the scope of the global illness burden due to CVD, the simplicity of the proposed test (ultrasound of carotids) and the smoking prevalence in Switzerland, the evaluation of new strategies for smoking cessation in long-term smokers and the primary prevention of CVD is an important public health priority.
Beyond the randomized 1-year study, we have extended the follow-up to 3 years and added abdominal aneurysm screening by ultrasound to the intervention group to assess the association between cardiovascular risk factors and the development of small abdominal aortic aneurysms.
- Conditions
- Smoking
- Being tested
- Carotid ultrasound for plaque screening, Brief advice for smoking cessation
- Keywords
- Atherosclerosis, Smoking cessation, Diagnostic techniques, cardiovascular, Ultrasonography, Health behavior
- Medical subject headings
- Smoking, Atherosclerosis, Smoking Cessation, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasound for plaque screeningDevice
Also called B-mode ultrasound (Vingmed 5; General Electric Medical System, Wisconsin, USA), coupled with the M'ATH software (Metris, France).
Carotid ultrasound for plaque screening
Brief advice for smoking cessationBehavioural
We will use the 5A's heuristic (Ask about smoking, Advise on cessation, Assess willingness to change, and for those willing to make quit attempt: Assist with attempt to quit, and Arrange for follow-up) and the gold standard for brief smoking cessation advice. At each visit, smokers will receive smoking cessation counseling and nicotine replacement therapy, similar to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Carotid plaque screening and brief advice for smoking cessation: Smokers with at least one carotid plaque will receive pictures of their own plaques with a structured explanation on the general significance of plaques. Receives: Device: Carotid ultrasound for plaque screening; Behavioral: Brief advice for smoking cessation |
| 2 | Active comparator | Brief advice for smoking cessation (without carotid ultrasound for plaque screening): to ensure equal contact conditions, smokers not undergoing ultrasound will receive a relevant explanation on the risks associated with tobacco smoking. Receives: Behavioral: Brief advice for smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence: one-week point prevalence abstinence, ascertained by self-report and confirmed by exhaled carbon monoxide (CO) and by the level of serum cotinine
Measured: 1 year, 3 years
Secondary outcomes (7)
Continuous smoking abstinence from quit date and one-week point prevalence abstinence, ascertained by self-report and confirmed by exhaled carbon monoxide (CO)
Measured: 8 weeks, 26 weeks, 1 year, 3 years
Change in control of other cardiovascular risk factors: low-density lipoprotein cholesterol, hemoglobin A1C (if diabetes), high-sensitivity C-reactive protein (hs-CRP) and blood pressure.
Measured: 1 year, 3 years
Change in overall cardiovascular risk, as measured by the Framingham risk score
Measured: 1 year, 3 years
Change in drug adherence, as measured by adherence questionnaire
Measured: 1 year, 3 years
Change in quality of life, as measured by SF-36
Measured: 1 year, 3 years
Change in physical activity, as measured by International Physical Activity Questionnaire questionnaire (IPAQ)
Measured: 1 year, 3 years
Increase in harms potentially associated with screening: stress and depression, as measured depression scores with the Beck Depression Inventory and the 4-item Perceived Stress Scale
Measured: 1 year, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Heart Foundation, Swiss Tobacco Prevention Funds
- Responsible party
- Principal investigator, Nicolas Rodondi, University of Lausanne
- Investigators
- Nicolas Rodondi, MD, MAS, Principal investigator, University of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548665
- Sponsor's protocol ID
- SNSF 3200B0-116097
- Acronym
- CAROSS
- Status last verified
- Dec 2014
- First submitted
- 23 Oct 2007
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodondi N, Bovet P, Hayoz D, Cornuz J. The Impact of CAROtid plaque Screening on Smoking (CAROSS) cessation and control of other cardiovascular risk factors: Rationale and design of a randomized controlled trial. Contemp Clin Trials. 2008 Sep;29(5):767-73. doi: 10.1016/j.cct.2008.03.001. Epub 2008 Mar 18.
PubMed 18424239Rodondi N, Auer R, Devine PJ, O'Malley PG, Hayoz D, Cornuz J. The impact of carotid plaque screening on motivation for smoking cessation. Nicotine Tob Res. 2008 Mar;10(3):541-6. doi: 10.1080/14622200801902011.
PubMed 18324574Rodondi N, Collet TH, Nanchen D, Locatelli I, Depairon M, Aujesky D, Bovet P, Cornuz J. Impact of carotid plaque screening on smoking cessation and other cardiovascular risk factors: a randomized controlled trial. Arch Intern Med. 2012 Feb 27;172(4):344-52. doi: 10.1001/archinternmed.2011.1326. Epub 2012 Jan 23.
PubMed 22269590Desgraz B, Collet TH, Rodondi N, Cornuz J, Clair C. Comparison of self-perceived cardiovascular disease risk among smokers with Framingham and PROCAM scores: a cross-sectional analysis of baseline data from a randomised controlled trial. BMJ Open. 2017 Jan 6;7(1):e012063. doi: 10.1136/bmjopen-2016-012063.
PubMed 28062468
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Carotid Plaque Screening on Smoking Cessation and Control of Other Cardiovascular Risk Factors: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00548665
- Acronym / sponsor ID
- CAROSS / SNSF 3200B0-116097
- Conditions
- Smoking
- Keywords
- Atherosclerosis, Smoking cessation, Diagnostic techniques, cardiovascular, Ultrasonography, Health behavior
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Heart Foundation, Swiss Tobacco Prevention Funds
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the impact of carotid plaque screening on smoking cessation and control of other cardiovascular risk factors.
Detailed description
Tobacco smoking is highly prevalent in Switzerland (31% of adults), and 50% of smokers die from a tobacco-related disease, mainly cardiovascular disease (CVD). The smoking prevalence makes the evaluation of new strategies for smoking cessation a crucial priority.
The presence of plaques of atherosclerosis ("cholesterol" deposits in the artery wall), as measured by carotid ultrasound, increases the risk of future CVD. The use of plaque screening to motivate patients to improve smoking cessation has received little attention. In one study, screening for atherosclerotic plaques increased the self-reported rates of smoking cessation, but without biochemical validation of cessation and these smokers had only low nicotine dependence. Moreover, no trial has examined the impact of plaque screening on the control of other cardiovascular risk factors.
We now propose a randomized controlled trial of carotid plaque screening in 530 regular smokers aged 40-70 years, recruited from the community, to measure the impact of plaque screening on smoking cessation(main outcome) and control of other cardiovascular risk factors (secondary outcomes) after 1-year follow-up. Secondary outcomes are low-density lipoprotein cholesterol, hemoglobin A1C (if diabetes), high-sensitivity C-reactive protein and blood pressure. Smokers will all receive advice for smoking cessation and, then, will be randomly assigned to either the intervention group (with plaque screening) or the control group (without plaque screening). Smokers with one or more carotid plaque will receive pictures of their own plaques with a standardized explanation. To ensure equal contact conditions, smokers not undergoing ultrasound or without plaque will receive a standardized explanation on the risks of tobacco smoking.
This study is innovative because plaque screening is a promising and increasingly used strategy to motivate patients to stop smoking and improve control of cardiovascular risk factors, but its effectiveness has been poorly studied. Successful completion of this project will provide a strong scientific basis for using this strategy for smoking cessation and control of cardiovascular risk factors. If testing is not an effective tool, such testing might represent an important waste of expenditure, and healthcare expenditures should be used for other strategies. Given the scope of the global illness burden due to CVD, the simplicity of the proposed test (ultrasound of carotids) and the smoking prevalence in Switzerland, the evaluation of new strategies for smoking cessation in long-term smokers and the primary prevention of CVD is an important public health priority.
Beyond the randomized 1-year study, we have extended the follow-up to 3 years and added abdominal aneurysm screening by ultrasound to the intervention group to assess the association between cardiovascular risk factors and the development of small abdominal aortic aneurysms.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Carotid ultrasound for plaque screening, Behavioral: Brief advice for smoking cessationCarotid plaque screening and brief advice for smoking cessation: Smokers with at least one carotid plaque will receive pictures of their own plaques with a structured explanation on the general significance of plaques. |
| 2 | Active comparator | Behavioral: Brief advice for smoking cessationBrief advice for smoking cessation (without carotid ultrasound for plaque screening): to ensure equal contact conditions, smokers not undergoing ultrasound will receive a relevant explanation on the risks associated with tobacco smoking. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current daily smoker with more or equal to 10 cigarettes per day for at least 1 year
- Age between 40 and 70 years
Key exclusion criteria (10 listed)
- Prevalent CVD at baseline, defined as a medical diagnosis or self-report of coronary heart disease, stroke or transient ischemic attack, peripheral arterial disease, carotid artery disease, congestive heart failure, or having a pacemaker.
- Unstable life-threatening or severe medical conditions (major arrhythmia, cancer,…)
- Current psychiatric disease
- Current substance abuse (cannabis, other drugs, alcohol abuse)
- Current use of pharmacological agent to quit smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid ultrasound for plaque screeningAlso: B-mode ultrasound (Vingmed 5; General Electric Medical System, Wisconsin, USA), coupled with the M'ATH software (Metris, France).Carotid ultrasound for plaque screening | Device | 1 |
| Brief advice for smoking cessationWe will use the 5A's heuristic (Ask about smoking, Advise on cessation, Assess willingness to change, and for those willing to make quit attempt: Assist with attempt to quit, and Arrange for follow-up) and the gold standard for brief smoking cessation advice. At each visit, smokers will receive smoking cessation counseling and nicotine replacement therapy, similar to the experimental group. | Behavioural | 1, 2 |
Primary outcome
Smoking abstinence: one-week point prevalence abstinence, ascertained by self-report and confirmed by exhaled carbon monoxide (CO) and by the level of serum cotinine
Time frame: 1 year, 3 years
7 secondary outcomes
Continuous smoking abstinence from quit date and one-week point prevalence abstinence, ascertained by self-report and confirmed by exhaled carbon monoxide (CO)
Time frame: 8 weeks, 26 weeks, 1 year, 3 years
Change in control of other cardiovascular risk factors: low-density lipoprotein cholesterol, hemoglobin A1C (if diabetes), high-sensitivity C-reactive protein (hs-CRP) and blood pressure.
Time frame: 1 year, 3 years
Change in overall cardiovascular risk, as measured by the Framingham risk score
Time frame: 1 year, 3 years
Change in drug adherence, as measured by adherence questionnaire
Time frame: 1 year, 3 years
Change in quality of life, as measured by SF-36
Time frame: 1 year, 3 years
Change in physical activity, as measured by International Physical Activity Questionnaire questionnaire (IPAQ)
Time frame: 1 year, 3 years
Increase in harms potentially associated with screening: stress and depression, as measured depression scores with the Beck Depression Inventory and the 4-item Perceived Stress Scale
Time frame: 1 year, 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 18424239Rodondi N, Bovet P, Hayoz D, Cornuz J. The Impact of CAROtid plaque Screening on Smoking (CAROSS) cessation and control of other cardiovascular risk factors: Rationale and design of a randomized controlled trial. Contemp Clin Trials. 2008 Sep;29(5):767-73. doi: 10.1016/j.cct.2008.03.001. Epub 2008 Mar 18.
- Background: PubMed 18324574Rodondi N, Auer R, Devine PJ, O'Malley PG, Hayoz D, Cornuz J. The impact of carotid plaque screening on motivation for smoking cessation. Nicotine Tob Res. 2008 Mar;10(3):541-6. doi: 10.1080/14622200801902011.
- Results publication: PubMed 22269590Rodondi N, Collet TH, Nanchen D, Locatelli I, Depairon M, Aujesky D, Bovet P, Cornuz J. Impact of carotid plaque screening on smoking cessation and other cardiovascular risk factors: a randomized controlled trial. Arch Intern Med. 2012 Feb 27;172(4):344-52. doi: 10.1001/archinternmed.2011.1326. Epub 2012 Jan 23.
- Derived from this study: PubMed 28062468Desgraz B, Collet TH, Rodondi N, Cornuz J, Clair C. Comparison of self-perceived cardiovascular disease risk among smokers with Framingham and PROCAM scores: a cross-sectional analysis of baseline data from a randomised controlled trial. BMJ Open. 2017 Jan 6;7(1):e012063. doi: 10.1136/bmjopen-2016-012063.
Related trials for Smoking
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Rodondi, MD, MAS principal investigator
University of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carotid ultrasound for plaque screening and Brief advice for smoking cessation in people with Smoking, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence: one-week point prevalence abstinence, ascertained by self-report and confirmed by exhaled carbon monoxide (CO) and by the level of serum cotinine (time frame: 1 year, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00548665, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.