Carotid Plaque Screening Trial in Smokers

NCT00548665 | Completed Phase 4

• 1 other identifier: SNSF 3200B0-116097
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

Atherosclerosis; Smoking cessation; Diagnostic techniques, cardiovascular; Ultrasonography; Health behavior

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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.

  1 year, 3 years

• Change in overall cardiovascular risk, as measured by the Framingham risk score

  1 year, 3 years

• Change in drug adherence, as measured by adherence questionnaire

  1 year, 3 years

• Change in quality of life, as measured by SF-36

  1 year, 3 years

Study Arms (2)

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.

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.

Behavioral: Brief advice for smoking cessation

Interventions

Carotid ultrasound for plaque screening DEVICE

Carotid ultrasound for plaque screening

Also known as: B-mode ultrasound (Vingmed 5; General Electric Medical System, Wisconsin, USA), coupled with the M'ATH software (Metris, France).

1

Brief advice for smoking cessation BEHAVIORAL

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.

1; 2

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne: lead
• Swiss National Science Foundation: collaborator
• Swiss Heart Foundation: collaborator
• Swiss Tobacco Prevention Funds: collaborator

Study Sites (1)

University of Lausanne

Lausanne, 1011, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 18424239 BACKGROUND

• Rodondi 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.

  PMID: 18324574 BACKGROUND

• Rodondi 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.

  PMID: 22269590 RESULT

• Desgraz 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.

  PMID: 28062468 DERIVED

MeSH Terms

Conditions

Smoking; Atherosclerosis; Smoking Cessation; Health Behavior

Interventions

Ultrasonography, Carotid Arteries; Crisis Intervention

Condition Hierarchy (Ancestors)

Behavior; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nicolas Rodondi, MD, MAS

  University of Lausanne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, MAS

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CH (1)