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Completed

NCT Number: NCT00987597

Smoking Cessation for Patients With Acute Coronary Syndrome (ACS)

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Lariboisière, APHP, Cardiology

Paris, Île-de-France Region, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technique of in-vivo exposure (cigarette) and mental image exposure (craving)

Behavioral

Nicotine replacement

Other names: Reduce the urge to smoke, Strategies to avoid the relapse

conventional follow-up

Behavioral

nicotinic substitutes

Other names: recommendations

Primary outcomes

  1. 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 outcomes

  1. Assessment depending of age classes, sex, anxiety scale and other psychological characteristics

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France
  • National Cancer Institute, France

Registry information

Official study 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

Acronym: PATPAC

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 1, 2009
Registry last updated
Dec 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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