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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT : 2008-00267712 | |||
| ID RCB : 2008-A00509-46 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| National Cancer Institute, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cognitive behavioural approach | Experimental | specific technique of cigarette exposure and nicotinic treatment adjustment |
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| usual approach | Active Comparator | recommendations and nicotinic substitutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technique of in-vivo exposure (cigarette) and mental image exposure (craving) | Behavioral | Nicotine replacement |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment depending of age classes, sex, anxiety scale and other psychological characteristics | 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick HENRY, MD,PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Laurent MAGNE | Cabinet MAGNE & GALLY | Study Director |
| Olivia GALLY | Cabinet MAGNE & GALLY | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lariboisière, APHP, Cardiology | Paris | Île-de-France Region | 75010 | France |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| D006287 | Health Planning Guidelines |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D006285 | Health Planning |
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| conventional follow-up | Behavioral | nicotinic substitutes |
|
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| D014652 |
| Vascular Diseases |
| D004472 | Health Care Economics and Organizations |