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Smoking Cessation for Patients With Acute Coronary Syndrome (ACS) (PATPAC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ministry of Health, France
National Cancer Institute, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00987597
First received: September 30, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Smoking
Acute Coronary Syndrome
 Behavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving)
Behavioral: conventional follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

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). [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment depending of age classes, sex, anxiety scale and other psychological characteristics [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: September 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cognitive behavioural approach
specific technique of cigarette exposure and nicotinic treatment adjustment
 Behavioral: Technique of in-vivo exposure (cigarette) and mental image exposure (craving)
Nicotine replacement
Other Names:
  • Reduce the urge to smoke
  • Strategies to avoid the relapse
Active Comparator: usual approach
recommendations and nicotinic substitutes
 Behavioral: conventional follow-up
nicotinic substitutes
Other Name: recommendations

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987597

Contacts
Contact: Patrick Henry 00-33-1-49 95 82 24 patrick.henry@lrb.aphp.fr

Locations
France
CHU Lariboisière, APHP, Cardiology Recruiting
Paris, Ile de France, France, 75010
Contact: Patrick Henry     00-33-1-49 95 82 24     Patrick.henry@lrb.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
National Cancer Institute, France
Investigators
Principal Investigator: Patrick HENRY, MD,PhD Assistance Publique - Hôpitaux de Paris
Study Director: Laurent MAGNE Cabinet MAGNE & GALLY
Study Director: Olivia GALLY Cabinet MAGNE & GALLY
  More Information

No publications provided

Responsible Party: Pr Patrick HENRY (Service de cardiologie), Hôpital LARIBOISIERE
ClinicalTrials.gov Identifier: NCT00987597     History of Changes
Other Study ID Numbers: LRB0801, EUDRACT : 2008-00267712, ID RCB : 2008-A00509-46
Study First Received: September 30, 2009
Last Updated: September 30, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Smoking
nicotine replacement
psychological behaviour
Smoking > 5 cigarettes per day
Hospitalisation for acute coronary syndrome

Additional relevant MeSH terms:
Smoking
Acute Coronary Syndrome
Habits
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
 Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013