Carotid Plaque Screening Trial in Smokers - Full Text View

Sponsors and Collaborators:	University of Lausanne Swiss Heart Foundation
Information provided by:	University of Lausanne
ClinicalTrials.gov Identifier:	NCT00548665

Purpose

The purpose of this study is to determine the impact of carotid plaque screening on smoking cessation and control of other cardiovascular risk factors.

Condition	Intervention	Phase
Smoking	Device: Carotid ultrasound for plaque screening Behavioral: Brief advice for smoking cessation	Phase IV

Study Type:	Interventional
Study Design:	Screening, Randomized, Double Blind (Caregiver, Outcomes Assessor), Parallel Assignment
Official Title:	Impact of Carotid Plaque Screening on Smoking Cessation and Control of Other Cardiovascular Risk Factors: A Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking Ultrasound

U.S. FDA Resources

Further study details as provided by University of Lausanne:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change in overall cardiovascular risk, as measured by the Framingham risk score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in drug adherence, as measured by adherence questionnaire [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Change in quality of life, as measured by SF-36 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Change in physical activity, as measured by International Physical Activity Questionnaire questionnaire (IPAQ) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	530
Study Start Date:	November 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Carotid plaque screening and brief advice for smoking cessation	Device: Carotid ultrasound for plaque screening Carotid ultrasound for plaque screening Behavioral: Brief advice for smoking cessation 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.
2: Active Comparator Brief advice for smoking cessation (without carotid ultrasound for plaque screening)	Behavioral: Brief advice for smoking cessation 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.

Arms

Assigned Interventions

1: Experimental

Carotid plaque screening and brief advice for smoking cessation

Device: Carotid ultrasound for plaque screening

Carotid ultrasound for plaque screening

Behavioral: Brief advice for smoking cessation

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.

2: Active Comparator

Brief advice for smoking cessation (without carotid ultrasound for plaque screening)

Behavioral: Brief advice for smoking cessation

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.

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 ³ 1 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.

Eligibility

Ages Eligible for Study:	40 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Current daily smoker with more or equal to 10 cigarettes per day for at least 1 year
Age between 40 and 70 years

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548665

Contacts

Contact: Nicolas Rodondi, MD, MAS

+41 21 314 60 75

Nicolas.Rodondi@hospvd.ch

Locations

Switzerland
University of Lausanne	Recruiting
Lausanne, Switzerland, 1011
Principal Investigator: Nicolas Rodondi, MD, MAS

Sponsors and Collaborators

University of Lausanne

Swiss Heart Foundation

Investigators

Principal Investigator:	Nicolas Rodondi, MD, MAS	University of Lausanne, Switzerland
Study Director:	Jacques Cornuz, MD, MPH	University of Lausanne, Switzerland

More Information

Additional Information:

Swiss National Scientific Foundation website This link exits the ClinicalTrials.gov site

No publications provided by University of Lausanne

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Mar 18.

Responsible Party:	University of Lausanne ( Bernard Decrauzat )
Study ID Numbers:	SNSF 3200B0-116097
Study First Received:	October 23, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00548665 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University of Lausanne:

Atherosclerosis
Smoking cessation
Diagnostic techniques, cardiovascular
Ultrasonography
Health behavior

Study placed in the following topic categories:

Nicotine polacrilex
Atherosclerosis
Smoking
Nicotine

Additional relevant MeSH terms:

Habits
Smoking

ClinicalTrials.gov processed this record on September 10, 2009