Clinical trial NCT00987597: Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Acute Coronary Syndrome
Keywords: Smoking
nicotine replacement
psychological behaviour
Smoking > 5 cigarettes per day
Hospitalisation for acute coronary syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: National Cancer Institute, France
First posted: 2009-10-01
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 6 month
Secondary outcomes:
measure: Assessment depending of age classes, sex, anxiety scale and other psychological characteristics
timeFrame: 6 month
Other outcomes:
Locations:
city: Paris
country: France
facility: CHU Lariboisière, APHP, Cardiology
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Patrick HENRY, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cabinet MAGNE & GALLY
name: Laurent MAGNE
role: STUDY_DIRECTOR
affiliation: Cabinet MAGNE & GALLY
name: Olivia GALLY
role: STUDY_DIRECTOR
References: