Back to resultsSmoking Cessation for Patients With Acute Coronary Syndrome (ACS) (PATPAC)
Primary Purpose
Smoking, Acute Coronary Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Technique of in-vivo exposure (cigarette) and mental image exposure (craving)
conventional follow-up
Sponsored by
About this trial
This is an interventional prevention trial for Smoking focused on measuring Smoking, nicotine replacement, psychological behaviour, Smoking > 5 cigarettes per day, Hospitalisation for acute coronary syndrome
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
Sites / Locations
- CHU Lariboisière, APHP, Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cognitive behavioural approach
usual approach
Arm Description
specific technique of cigarette exposure and nicotinic treatment adjustment
recommendations and nicotinic substitutes
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Assessment depending of age classes, sex, anxiety scale and other psychological characteristics
Full Information
NCT ID
NCT00987597
First Posted
September 30, 2009
Last Updated
December 23, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France, National Cancer Institute, France
1. Study Identification
Unique Protocol Identification Number
NCT00987597
Brief Title
Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)
Acronym
PATPAC
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France, National Cancer Institute, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Acute Coronary Syndrome
Keywords
Smoking, nicotine replacement, psychological behaviour, Smoking > 5 cigarettes per day, Hospitalisation for acute coronary syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive behavioural approach
Arm Type
Experimental
Arm Description
specific technique of cigarette exposure and nicotinic treatment adjustment
Arm Title
usual approach
Arm Type
Active Comparator
Arm Description
recommendations and nicotinic substitutes
Intervention Type
Behavioral
Intervention Name(s)
Technique of in-vivo exposure (cigarette) and mental image exposure (craving)
Other Intervention Name(s)
Reduce the urge to smoke, Strategies to avoid the relapse
Intervention Description
Nicotine replacement
Intervention Type
Behavioral
Intervention Name(s)
conventional follow-up
Other Intervention Name(s)
recommendations
Intervention Description
nicotinic substitutes
Primary Outcome Measure Information:
Title
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).
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Assessment depending of age classes, sex, anxiety scale and other psychological characteristics
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick HENRY, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent MAGNE
Organizational Affiliation
Cabinet MAGNE & GALLY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Olivia GALLY
Organizational Affiliation
Cabinet MAGNE & GALLY
Official's Role
Study Director
Facility Information:
Facility Name
CHU Lariboisière, APHP, Cardiology
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)
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