Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)

Study Overview
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Brief Summary
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The aim of the present study is to assess if a personal care program of smokers hospitalised for acute coronary syndrome can change the smoking habits as compared with similar patients in conventional care program at 6 months. The program includes a cognitive-behavioural approach associated with a nicotine replacement treatment presented as an obligatory non optional treatment. Patients are men and women of less than 70 years old hospitalised for acute coronary syndrome. Major exclusion criteria is the presence of another dependence. The program includes a cognitive-behavioural approach based on the specific technique of exposure and the prescription of nicotine patch considered as other usual cardiologic treatments for at least 6 months. The end point is the smoking habits at 6 months classified as: no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm). 72 patients in each group will be included in 2 majors sites.

Detailed Description
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The cognitive behavioural approach group : This group will receive an inclusion visit at first, then two cigaret exposures cessions during hospitalisation. Thereafter-one week after he's out- the patient will come for 5 follow up visits consisting in the specific technique of cigaret exposure and nicotinic treatment adjustment. Then the last visit, at six months, will tell us if the patient is an effective non smoker or not; We'll be also collecting psychological and medical informations (such as the treatment, IMC, cardiovascular check up and psychological tests). The control group : This group is managed as usual : the nurse gives very rapid recommendations to the patients concerning smoking cessation. Nicotinic substitutes are proposed to the patients but the patient must find them by itself.

Official Title
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Effectiveness of a Managed Care Smoking Cessation Program in Patients With Acute Coronary Syndrome Based on Nicotine Replacement as a Treatment and a Cognitive-behavioral Approach

Conditions
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Smoking, Acute Coronary Syndrome

Intervention / Treatment
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* Behavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving)
* Behavioral: conventional follow-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are men and women of less than 70 years old Hospitalised for acute coronary syndrome in cardiology Intensive Care Unit Active smoking >5 cigarettes/day Has given consent to participate in the study and haven't expressed its opposition the exploitation of data as part of the study Exclusion Criteria: Presence of another dependence : alcohol abuse avowed or strongly suspected, addiction to drugs, high dose benzodiazepine dependence. clinical assessment Major psychiatric disorders or history. clinical assessment Treatment with lithium and neuroleptic. clinical assessment Patient whose cardiac problem could lead to hemodynamic instability during 48 h after admission. Patient scheduled for programmed hospitalisation within 6 months after release from hospital (>3 days long, including coronary bypass) Patients presenting another severe pathology requiring 6 months specific treatments. clinical assessment Patient which cannot understand or read French Patient with possible side-effect to nicotine substitute Patient unaffiliated to any social security regime

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive behavioural approach<br>specific technique of cigarette exposure and nicotinic treatment adjustment | Behavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving)<br>* Nicotine replacement<br>* Other names: Strategies to avoid the relapse;|
| Active Comparator: usual approach<br>recommendations and nicotinic substitutes | Behavioral: conventional follow-up<br>* nicotinic substitutes<br>* Other names: recommendations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The smoking habits at 6 months classified as : no smoking confirmed by CO measurement, smoking or doubtful (declaration of no smoking by the patient but a CO level > 10 ppm). |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment depending of age classes, sex, anxiety scale and other psychological characteristics |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, nicotine replacement, psychological behaviour, Smoking > 5 cigarettes per day, Hospitalisation for acute coronary syndrome