NCT00987597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 26, 2016

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

September 30, 2009

Last Update Submit

December 23, 2016

Conditions

SmokingAcute Coronary Syndrome

Keywords

Smokingnicotine replacementpsychological behaviourSmoking > 5 cigarettes per dayHospitalisation for acute coronary syndrome

Outcome Measures

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).

    6 month

Secondary Outcomes (1)

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

    6 month

Study Arms (2)

cognitive behavioural approach

EXPERIMENTAL

specific technique of cigarette exposure and nicotinic treatment adjustment

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

usual approach

ACTIVE COMPARATOR

recommendations and nicotinic substitutes

Behavioral: conventional follow-up

Interventions

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

Nicotine replacement

Also known as: Reduce the urge to smoke, Strategies to avoid the relapse
cognitive behavioural approach
conventional follow-upBEHAVIORAL

nicotinic substitutes

Also known as: recommendations
usual approach

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Lariboisière, APHP, Cardiology

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

Location

MeSH Terms

Conditions

SmokingAcute Coronary Syndrome

Interventions

Tobacco ProductsHealth Planning Guidelines

Condition Hierarchy (Ancestors)

BehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and AgricultureHealth PlanningHealth Care Economics and Organizations

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

September 1, 2008

Primary Completion

October 1, 2009

Study Completion

April 1, 2010

Last Updated

December 26, 2016

Record last verified: 2013-11

Locations

FR(1)